Meds Entry Watch, 6th Edition

Executive Summary

This is the sixth edition of the PMPRB’s Meds Entry Watch report, which explores the market entry of new medicines in Canada and other countries. Building on a retrospective analysis of trends since 2016, this report focuses on medicines that received first-time market approval through the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2019 and 2020, and analyzes their uptake, pricing, sales, and availability as of the last quarter of 2020 (Q4-2020).

In addition to the international analysis, a Canadian-focused section provides information on medicines that received their first Health Canada approval in 2019, as well as a retrospective review of annual marketing rates over the past five years.

This publication informs decision makers, researchers, and patients of the evolving market dynamics of emerging therapies in Canadian and international pharmaceutical markets.

Key Findings

A) Trends in New Medicine Approvals, 2015 to 2020

An average of 45 new medicines were approved each year from 2015 to 2020, with orphan and oncology medicines making up a significant portion of new approvals.

• Across Canada, US, and Europe, 50 new medicines were approved in 2020, up slightly from 47 in 2019.
• Orphan and oncology shares of new approvals have fluctuated over the past five years, averaging 50% and 28%, respectively.

A considerable portion of the new medicines approved internationally between 2015 and 2019 had Canadian sales by the end of 2020.

• New medicines approved between 2015 and 2019 accounted for approximately 15% of brand-name medicine sales in Canada in Q4-2020.
• There were sales in Canada for 37% of these medicines by the end of 2020, placing Canada ahead of the OECD median of 32%.
• New medicines with Canadian sales accounted for 85% of all new medicine sales in the OECD in Q4-2020, indicating that the higher-selling medicines continue to be among those approved and sold in Canada.

Canada outpaced the PMPRB11 median in terms of the number of new medicines sold within one year of their first international approval.

• Canada had recorded sales for 30% of 2015 to 2019 new medicines within the calendar year following first international approval, placing it fifth among the PMPRB11 countries.
• Over this five-year period, the share of new medicines approved and sold in Canada by the end of the following calendar year fluctuated from a high of 38% in 2017 to a low of 22% in 2018.

B) 2019 New Medicine Approvals

Forty-seven new medicines were approved in 2019, more than half of which had high treatment costs.

• 47 new medicines received market approval through the FDA, the EMA, and/or Health Canada in 2019.
• 40% of the 2019 new medicines received an orphan designation from the FDA and/or the EMA, while 23% were indicated for the treatment of cancer.
• Over 60% of new medicines with sales had high treatment costs: 10 oncology medicines had costs exceeding $5,000 per 28-day cycle and 16 non-oncology medicines had annual costs exceeding $10,000.

Fewer new medicines were approved by Health Canada than by the FDA and EMA, although Canada performed better than the OECD median and most PMPRB11 countries in terms of the number of new medicines with sales.

• 19 of the 47 new medicines first approved in 2019 had market authorization in Canada by Q4-2020, compared to 44 approved by the FDA and 24 by the EMA.
• Of the 19 approved medicines, 11 had recorded sales in Canada by the end of 2020, placing Canada third in the PMPRB11 countries and fifth in the OECD and third in the PMPRB11 countries for the number of new medicines with sales—an improved standing over previous years.
• Medicines approved and sold in Canada by Q4-2020 represented 49% of all new medicines sales in the OECD. This share is in line with comparator countries but lower than in previous years, due in large part to a later approval date for the top-selling 2019 medicine elexacaftor (Trikafta).

Sales for 2019 new medicines were highly concentrated, with two medicines accounting for almost 50% of OECD revenues for new approvals in the last quarter of 2020.

• Respiratory system products were the top-selling therapeutic class with 25% of OECD new medicines sales in Q4-2020, represented exclusively by the new medicine elexacaftor (Trikafta), which is used in the treatment of cystic fibrosis.
• Nonsteroidal products for anti-inflammatory skin disorders, represented by the plaque psoriasis treatment risankizumab (Skyrizi), accounted for approximately 23% of new medicine sales in the OECD. Risankizumab was also one of the most widely marketed new medicines, with sales in Canada, the US, and 10 of the PMPRB11 countries.

C) 2020 New Medicine Approvals

While the number of new medicines approved in 2020 was similar to 2019, the share of oncology and orphan medicines was notably higher.

• 50 new medicines received market approval through the FDA, the EMA, and/or Health Canada in 2020. Of these, 19 were approved in Canada by the third quarter of 2020.
• In total, 58% (29) of the new medicines received an orphan designation from the FDA and/or the EMA while oncology treatments accounted for 34% (19) of the 2020 new medicines.
• Of the 32 medicines with sales by Q4-2020, 24 (75%) had treatment costs exceeding $10,000 per year or $5,000 per 28-day course.

D) Spotlight on Canada

Canada approved 34 new medicines in 2019, including many of the international top-sellers from the same year.

• 34 new-to-Canada medicines were approved for market in 2019, of which 20 had reported sales by Q4-2020.
• Almost half (16) of the 2019 Canadian approvals were indicated to treat cancer.
• Three of the five international top-selling new medicines in 2019 received approval and had sales in Canada in the same year, including risankizumab (Skyrizi), which represented 45% of all 2019 new-to-Canada medicine sales in Q4-2020.
• From 2016 to 2020, between 82% and 95% of medicines approved in Canada had sales by the end of the following calendar year.

Introduction

Meds Entry Watch is an annual PMPRB publication that explores the dynamics of new medicines entering Canadian and international markets, providing information on their availability, sales, and prices.

This report builds on the five previous editions to provide a broad analysis of medicines that have received market approval since 2015, with a special focus on medicines approved in 2019 and 2020. New medicines are identified for each year based on the date of their first market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada.

The report consists of four main sections: Section A provides an overview of trends from 2015 to 2020; Section B focuses on new medicines that received international market approval in 2019; Section C presents a preliminary analysis of the new medicines approved internationally in 2020; and Section D spotlights Health Canada approvals in 2019.

This publication informs decision makers, researchers, and patients of emerging therapies in Canadian and international pharmaceutical markets.

Methods

This report analyzes new medicines that received first-time market approval from the FDA, the EMA, and/or Health Canada since 2015, with a focus on those approved in 2019 and 2020. A new medicine is selected for analysis if it received market authorization from any of these regulatory bodies during the calendar year for the first time, even if it was not yet listed for reimbursement or if there were no recorded sales in the available source data. For the purposes of this analysis, new medicines are identified at the medicinal ingredient level.

Using these criteria, 222 new medicines were identified as new approvals between 2015 and 2019, including the 47 new approvals in 2019 analyzed in Section B, and 50 medicines identified for the preliminary analysis in 2020 and presented in Section C. The approval of these medicines in Canadian and international markets was assessed as of the end of 2020 and the third quarter of 2021 (Q3-2021).

The selection of medicines featured in the analysis of the Canadian market in Section D differs from the previous sections. Medicines analyzed in Section D include new and previously marketed medicinal ingredients that received their first Canadian market authorization through Health Canada in 2019. This includes a number of medicines in the 2019 analysis in Section B, but also encompasses additional medicines that may have received initial approval through the FDA or EMA in previous years but were first approved for the Canadian market in 2019. Marketed status for Canadian approvals was sourced from Health Canada’s Drug Product Database.

International markets examined include the Organisation for Economic Co-operation and Development (OECD) countries, with a focus on Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom (UK), which will comprise the 11 PMPRB Schedule Countries (“PMPRB11”) specified in the amended Patented Medicine Regulations, which are scheduled to come into force on July 1, 2022. Results for the United States (US) are also provided for comparison purposes.

The IQVIA MIDAS® Database (all rights reserved) is the main data source for the sales and list prices of new medicines in Canadian and international markets, as well as the volume of units sold. MIDAS data reflects the national retail and hospital sectors for each country, including all sales (public, private, and out-of-pocket). Sales and volume data encompass all versions of a medicine available in a particular country, produced by any manufacturer in any strength and form. For more information on the MIDAS Database and other NPDUIS source materials, see the Resources section of the Analytical Studies page on the PMPRB website.

Canadian prices are based on MIDAS data, if available; otherwise, they are derived from publicly available results of the Reimbursement Review reports published by the Canadian Agency for Drugs and Technologies in Health (CADTH). Treatment costs are calculated using Canadian list prices where possible; if not, the foreign median price is used. Information on dosing regimens is taken from the product monographs published by Health Canada, or if not available, from the FDA or EMA. All medicines were reviewed as of Q3-2021, unless otherwise specified.

Prices and foreign-to-Canadian price ratios are reported for the highest-selling form and strength of each medicine in Canada, or in the PMPRB11 if no Canadian sales were available at the time of the analysis. The foreign-to-Canadian price ratios presented in this report are expressed as an index with the Canadian price set to a value of one and the international median reported relative to this value. For more details on how foreign-to-Canadian price ratios are calculated, see the Resources section of the Analytical Studies page on the PMPRB website.

Prices and sales in foreign currencies are converted into Canadian dollars using the 12-month or 3-month average exchange rate for the year or quarter, respectively.

Limitations

New medicines reported in Sections A, B, and C are selected for analysis based on their date of market approval by the FDA, the EMA, and/or Health Canada. Some of the medicines reported may have earlier approval dates in other countries, such as Australia and Japan, which are governed by other regulatory bodies. Likewise, the medicines included in this analysis do not necessarily represent all of those introduced in 2019 and 2020, as other national regulatory bodies not examined in this report may have approved additional medicines. Nevertheless, as the FDA and EMA represent significant international markets, this is estimated to have little effect on the overall results.

This report reflects the initial market penetration of these new medicines, and their availability and uptake are expected to increase in subsequent years. The availability of a new medicine in a given country at any point in time is influenced by a variety of factors including the manufacturer’s business decision to launch, as well as the timing of that decision; the regulatory approval process in place; and the existing market dynamics.

Market approval through the EMA does not necessarily mean that the medicine is available in any European country. Likewise, medicines approved through the FDA or Health Canada may not necessarily be marketed, reimbursed, and/or have any recorded sales.

Some medicines with sales may not be reported in the IQVIA MIDAS® Database, and thus, the sales of new medicines may be slightly under-reported. However, as the effect is expected to be approximately consistent across all markets, this should not have an impact on the overall findings.

Canadian and international sales and prices are based on manufacturer list prices as reported in the MIDAS Database, and do not capture price rebates, managed entry agreements (also known as product listing agreements), dispensing fees, or patient access schemes. The methodology used by MIDAS for estimating prices varies by country and data availability.

Publicly available prices from the Canadian Agency for Drugs and Technologies in Health (CADTH) are based on the manufacturers’ submitted list prices, which may differ upon market entry.

Aggregated international sales and pricing data are skewed towards the United States and, as a result, the ranking of medicines by international sales generally reflects the order of sales in the US.

The assessment of medicine availability in Canada does not consider non-marketed medicines available through exceptional programs such as the Special Access Program in Canada (SAP).

A: Trends in New Medicine Approvals, 2015–2020

An average of 45 new medicines received first-time market approval through the FDA, the EMA, and/or Health Canada annually between 2015 and 2020 (Figure A1). In 2019, 47 new medicines were approved, of which over 40% (19) received an orphan designation for at least one indication from the FDA and/or EMA, and approximately one quarter (11) were indicated to treat cancer.

An additional 50 new medicines were approved in 2020, including greater shares of orphan and oncology treatments: orphan medicines accounted for 58% of new approvals while oncology medicines rose to 34%, the highest share since 2015.

Figure A2 illustrates the year-over-year uptake in sales for medicines first approved between 2015 and 2019. By Q4-2020, these medicines collectively accounted for 15.5% of the total brand-name pharmaceutical market in Canada and 14.4% of international sales. Medicines that were approved in 2019 represented 0.8% of all pharmaceutical sales in Canada and the PMPRB11.^{Footnote 1}

In any given year, the impact of new medicines on pharmaceutical sales depends on their number, therapeutic relevance, and treatment costs. For example, direct-acting antiviral medicines approved in 2016 for the treatment of hepatitis C quickly gained large market shares by 2018, but have since started to decline, due in part to the curative nature of these treatments. By Q4-2020, the highest-selling new medicines in Canada were semaglutide, a diabetes medicine introduced in 2017, and palbociclib and daratumumab, two cancer medicines introduced in 2015.

Of the 222 medicines approved from 2015 to 2019, 83 (37%) had sales in Canada by Q4-2020 (Figure A3). While Canada’s proportion of new medicines with sales was higher than the OECD median of 32%, it ranked below the median of the PMPRB11 countries, many of which have lower average list prices for patented medicines than Canada (PMPRB 2021). The new medicines sold in Canada accounted for 85% of the OECD sales for all new medicines analyzed, representing the ninth-highest share in the OECD, well above the median of 76%. These findings are consistent with those observed in previous editions of Meds Entry Watch and continue to suggest that most of the top-selling new medicines in the OECD are being sold in Canada. Similar results have also been found in targeted analyses of the expensive drugs for rare diseases and oncology market segments (PMPRB 2020; 2022).

While Figure A3 provides an overview of the current uptake for this basket of medicines, it does not provide a complete picture of the time-to-market for new medicines in Canadian and international markets. To explore this factor, Figure A4 uses a retrospective analysis to identify the number of new medicines that were approved and marketed in Canada and comparator countries by the end of the calendar year following their first international authorization.

Of the 222 new medicines first approved between 2015 and 2019, Canada had recorded sales for 66 (30%) within one year of their first international approval. Canada outperformed the PMPRB11 median of 62, ranking higher than France, Italy, Japan, the Netherlands, Spain, Belgium, and Australia.

The US was an outlier among the countries shown, having recorded sales for 182 (82%) of the new medicines within a one-year period. Of the PMPRB11 countries, only Germany marketed more than 100 new medicines within a one-year period.

Figure A5(a) illustrates the percentage of new medicines approved and sold in Canada within one year of first international approval for each year from 2015 to 2019. The results indicate that Health Canada approved approximately half of 2015–2017 new medicines within a year of their international authorization, and closer to 40% of the medicines from 2018 and 2019. Previous editions of Meds Entry Watch have shown a similar decline in the proportion of medicines approved within one calendar year by the EMA during the same period.

Shares of new medicines with sales in Canada within the same period were approximately 15 percentage points lower than for approvals, fluctuating between a low of 22% to a high of 38%, for 2018 and 2017 new medicines, respectively.

These medicines accounted for a substantial proportion of the total sales for new medicines in the OECD. As shown in Figure A5(b), new medicines from 2015 to 2017 that were sold in Canada within one year of international approval represented 80% to 90% of OECD sales.

The share of sales declined for medicines approved in 2018 and 2019, falling to 75% and 49%, respectively. This dip is primarily attributable to differences in the marketing of Trikafta, which accounted for 25% of OECD sales of medicines approved in 2019 but was not approved in Canada until June 2021.

B: New Medicine Approvals, 2019

Forty-seven new medicines received their first market approval from Canada, Europe, and the US in 2019. By the end of 2020, 19 of these medicines had been approved by Health Canada, 24 by the EMA, and 44 by the US FDA (Figure B1).

Of the 19 medicines approved in Canada, 11 had sales data available in MIDAS by Q4-2020. This placed Canada fifth in the OECD and third in the PMPRB11 in terms of the number of new medicines sold. Despite Canada’s high number of approvals, its corresponding share of total new medicine sales was heavily influenced by the top-selling 2019 new medicine Trikafta, which accounted for 25% of OECD new medicine sales in Q4-2020 and was not approved in Canada until 2021. If Trikafta were omitted from the analysis, Canada’s total share of OECD new medicine sales would increase from 49% to 66%, compared to the OECD median of 36% and 48%, respectively.

These results reflect initial market penetration, and the availability and uptake in sales for these new medicines are expected to increase in subsequent years.

Table B1 lists the new medicines approved in 2019. For each medicine, the country with the first reported sales is given, along with the availability in Canada, the share of sales in Q4-2020, and the prices and corresponding treatment costs.^{Footnote 2} Prices are reported for the highest-selling form and strength of each medicine at the time of the analysis.

Antineoplastics continued to account for the greatest number of new medicines in 2019, with 10 medicines approved. Antivirals, which have been an important therapeutic class in recent years, only produced one new medicine in 2019 and had no reported sales. In total, the list of 2019 new medicines spanned 26 therapeutic classes.

Despite the range of therapeutic areas represented, sales for the 2019 new approvals were highly concentrated. The top three therapeutic classes, each represented by only one medicine, accounted for 60% of all new medicine sales across the OECD by Q4-2020 (Table B1).

Respiratory system products topped the list with one quarter (25%) of all sales, driven exclusively by Trikafta, a combination therapy treating cystic fibrosis. The therapy is a combination of three active ingredients: the 2012 medicine ivacaftor, the 2018 medicine tezacaftor, and the 2019 new medicine elexacaftor.

Nonsteroidal products for anti-inflammatory skin disorders followed with a 23% share of sales for risankizumab (Skyrizi), indicated for the treatment of plaque psoriasis. The strong sales of risankizumab may be attributed to its wide international market development, as it was sold in Canada, the US, and all but one PMPRB11 country by Q4-2020.

Musculo-skeletal medicines were the third highest-selling therapeutic class, driven solely by the rheumatoid arthritis treatment upadacitinib (Rinvoq). Upadacitinib was the only medicine to reach all 13 countries and was responsible for over 11% of sales by the end of 2020.

Despite having the greatest number of new medicines (10), antineoplastics collectively accounted for just 10% of new medicine sales. Analgesics ranked fifth among the top-selling therapeutic classes with 9% of the new medicine market, attributed to two new migraine treatments. Ubrogepant (Ubrelvy) was the strongest sales contributor in the class, with over 8% of 2019 new medicine sales.

In total, 40% (19) of the 2019 new medicines received an orphan designation from the FDA and/or the EMA. Approximately 23% (11) of new medicines were for the treatment of cancer and 30% (14) were biologics. There is a notable overlap between these categories, as illustrated in Figure B3.

Two gene therapies were approved in 2019. Onasemnogene abeparvovec (Zolgensma), an orphan medicines indicated for the treatment of spinal muscular atrophy, accounted for 2.6% of new medicine sales despite being sold in only one country. Betibeglogene autotemcel (Zynteglo), a treatment for beta thalassaemia first approved by the EMA, was among the seven new medicines that had not registered any sales in Q4-2020. Other medicines without recorded sales include diagnostic agents and vaccines, which are not always sold through conventional mechanisms and may be underreported by the data source.

Table B1 New medicines approved in 2019, availability, share of sales, prices, and treatment costs, ranked by therapeutic class share of sales, Q4-2020

Of the 40 new medicines with available treatment costs, 65% cost over $10,000 per year or $5,000 per 28-day cycle. Ten of eleven new oncology medicines fell into this “high-cost” category, along with more than half of non-oncology medicines. Eight non-oncology and five oncology medicines were identified as expensive drugs for rare diseases (EDRDs)—orphan-designated therapies exceeding $100,000 in annual treatment costs, or $7,500 per 28-day cycle. Together, these 12 EDRDs accounted for over 36% of 2019 new medicine sales.

Prior to being marketed in Canada, medicines must be reviewed and authorized by Health Canada. However, to be added to the formulary of public insurers, medicines must also be assessed by the Canadian Agency for Drugs and Technologies in Health (CADTH), an independent, non-for-profit health technology assessment organization.^{Footnote 3} Depending on the results of this assessment, the pan-Canadian Pharmaceutical Alliance (pCPA)—a consortium of public drug plans that conducts joint negotiations for brand-name and generic drugs in Canada—may then choose to enter price negotiations with pharmaceutical manufacturers prior to the drugs being added to public formularies.

As of Q3-2021, 24 of the medicines first approved in 2019 had been authorized for market in Canada. Of this group, 12 had been reviewed through CADTH’s reimbursement review process, all receiving a recommendation to “reimburse with conditions”. Five of the 24 new medicines approved in Canada had completed pCPA negotiations by Q3-2021 and seven others had negotiations underway; the remaining 11 medicines had no record of negotiation.

A review of private drug plan data found that half (12) of the 24 new medicines had been reimbursed by a private drug plan in Canada by Q3-2021. These are early results and the rates of reimbursement for new medicines can be expected to increase in the coming years.

The PMPRB’s Human Drug Advisory Panel (HDAP), which conducts scientific reviews of new patented medicines, found that 12 of the 14 new medicines reviewed demonstrated slight or no improvement over their therapeutic comparators. The remaining 10 medicines had not yet been reviewed as of Q3-2021.^{Footnote 4}

Table B2 provides an overview of the recommendations and negotiation status for the 24 approved medicines, as well as information on whether these medicines have recorded sales through private drug plans in Canada.

Table B3 provides further details on the pharmacoeconomic assessments conducted by CADTH through its review process, including the indications assessed, the recommended condition for reimbursement, the primary evaluation, the range of reported incremental cost-effectiveness ratios (ICER) reported, and the price reduction required for the medicine to achieve an ICER of $50,000 per quality-adjusted life year (QALY). The results suggest that none of the new medicines reviewed by CADTH were cost-effective at the submitted price. Accordingly, all were recommended to be approved on the condition that their price be reduced; price reductions needed to reach the $50,000/QALY level were estimated in 12 of the 15 available reports, ranging from 5% to over 90% of the submitted price. Of the 12 medicines, none produced an ICER below $50,000/QALY and some produced values as high as $2 million.

Table B3 Summary of Reimbursement Review assessments for 2019 new medicines approved in Canada by Q3-2021

C: New Medicine Approvals, 2020

Fifty new medicines received first-time market approval through the FDA, the EMA, and/or Health Canada in 2020. As of the third quarter of 2021, Health Canada had approved 19 of these new medicines, trailing the EMA (28) and the FDA (47) (Figure C1). Note that manufacturers may choose to submit new medicines for approval in the US, Europe, and Canada at different times, which may affect the number of medicines approved by each regulator.

Table C1 provides a full list of the 50 new medicines approved in 2020 along with the country with first reported sales, availability in Canada, and price and treatment cost where available.^{Footnote 5} Prices are reported for the highest-selling form and strength of each medicine. Note that this information reflects the early availability and uptake of these medicines in the markets analyzed.

By Q4-2020, 32 of the new medicines had sales in Canada, the US, and/or the PMPRB11. Three quarters (24) of these had treatment costs exceeding $10,000 per year or $5,000 per 28-day course for oncology medicines, placing them in the high-cost category. Remdesivir, which is indicated for the treatment of COVID-19, was the new medicine sold in the most countries by Q4-2020, with sales recorded in six markets, including Canada. The Pfizer-BioNTech COVID-19 mRNA vaccine Comirnaty was also first approved in 2020, though no sales were recorded before the end of the year.

Figure C2 illustrates the overlap between the number of new specialty medicines authorized for market in 2020. Of the 50 new medicines approved in 2020, 58% (29) had received an orphan designation from the FDA and/or the EMA and 34% (19) were oncology treatments. Approximately 30% (15) of the new approvals were orphan oncology medicines. Biologics accounted for 38% (19) of the 2020 new medicines.

Table C1 New medicines approved in 2020, availability, prices, and treatment costs, Q4-2020

Medicines without sales data in MIDAS^® as of Q4-2020 – date of approval by FDA, EMA, and/or Health Canada.

Medicine (trade name, form, strength, volume)	Therapeutic class*	Date of approval by FDA, EMA, and/or Health Canada
Abametapir (Xeglyze)	P03-Ectoparasiticides, incl. scabicides, insecticides and repellents	FDA	Jul-20
Ansuvimab-zykl (Ebanga)B,O	Not assigned as of Q3-2021	FDA	Dec-20
Atoltivimab, maftivimab, and odesivimab-ebgn‡‡ (Inmazeb)B,O	Not assigned as of Q3-2021	FDA	Oct-20
Berotralstat (Orladeyo)B	B6-All other haematological agents	FDA	Dec-20
Clascoterone (Winlevi)	D10-Anti-acne preparations	FDA	Aug-20
Inebilizumab (Uplizna)B,O	N7-Other central nervous system drugs	FDA	Jun-20
Lonafarnib (Zokinvy)O	V3-All other therapeutic products	FDA	Nov-20
Lumasiran (Oxlumo)O	G4-Urologicals	EMA	Nov-20
Naxitamab (Danyelza)B,C,O	L1-Antineoplastics	FDA	Nov-20
Oliceridine (Olinvyk)	N2-Analgesics	FDA	Aug-20
Relugloix†† (Orgovyx)C	L2-Cytostatic hormone therapy	FDA	Dec-20
Setmelanotide (Imcivree)O	A08-Antiobesity preparations, excl. diet products	FDA	Nov-20
Somapacitan (Sogroya)B	H01-Pituitary and hypothalamic hormones and analogues	FDA	Aug-20
Tirbanibulin (Klisyri)	D5-Nonsteroidal products for inflammatory skin disorders	FDA	Dec-20
Imlifidase (Idefirix)B	L04-Immunosuppressants	EMA	Aug-20
COVID-19 MRNA vaccine (Comirnaty)B	J7-Vaccines	EMA	Dec-20
Brexucabtagene autoleucel (Tecartus)B,C,G,O	L1-Antineoplastics	FDA	Jul-20
Coagulation Factor VIIa [Recombinant] (Sevenfact)B	B2-Blood coagulation system, other products	FDA	Apr-20