Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2022 print issue.
Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?
Despite the continued turbulence from COVID-19, the bio/pharma industry experienced another good year for drug approvals in 2021. The latest available figures from the European Medicines Agency (EMA) showed that 2021 marketing authorizations were granted to 82 therapies, 14 of which were for generic medicines and seven of which were for biosimilars (1).
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2022 print issue.
However, a drug that has been hitting headlines and was highlighted as ‘one to watch’ by Clarivate in 2021 (2), aducanumab from Biogen and Eisai, has not gained a favourable decision from EMA (3). Main reasons for the refusal of the marketing authorization of the drug included the fact that the effect of amyloid beta reduction in the brain and clinical improvement from Alzheimer’s has not been established, conflicting study results, and insufficient proof of safety (3). The three remaining drugs from the four highlighted in Clarivate’s 2021 report (2), bimekizumab, relugolix, and vericiguat, all gained marketing authorization in the European Union.
For 2022, Clarivate has highlighted seven late-stage treatments that its analysts expect to reach blockbuster status (i.e., earn US$1 billion [€873 million] or more in annual revenue) in the next five years. The therapies that have been picked out are adagrasib from Mirati Therapeutics and Zai Lab, faricimab from Roche and Chugai Pharmaceutical, lecanemab from Eisai and Biogen, donanemab from Eli Lilly and Company, tezepelumab from Amgen and AstraZeneca, tirzepatide from Eli Lilly and Company, and vutrisiran from Alnylam Pharmaceuticals (4).
The therapeutic targets for these treatments range from Alzheimer’s disease to cancer and eye disease to asthma, and the majority of the drugs fall under the classification of biologics. Projected sales for all of the drugs highlighted are reasonably similar with the exception of tirzepatide, which the analysts predicted could make US$4.55 billion (€3.97 billion) in sales by 2026 (4).
Only time will tell as to whether or not these promising medicines will indeed be the next ‘blockbusters’.
1. EMA, European Public Assessment Reports available from ema.europa.eu [Accessed 13 Jan. 2022].
2. Clarivate, Drugs to Watch 2021, Report (March 2021).
3. EMA, “Refusal of the Marketing Authorization for Aduhelm (Aducanumab),” Regulatory Document, 17 Dec. 2021.
4. Clarivate, Drugs to Watch 2022, Report (January 2022).
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Pharmaceutical Technology Europe
Vol. 34, No. 1
January 2022
Page: 6
When referring to this article, please cite it as F. Thomas, “Hot Picks for 2022,” Pharmaceutical Technology Europe 34 (1) 2022.