Last year, the EMA recommended a total of 92 medicines for marketing authorization and of these approvals, 35 contained a new active substance.
The number of applications for biosimilar medicines continues to grow year over year, with 17 applications received by the EMA in 2017, compared with 14 in 2016. The EMA also reported that this is the highest number of applications it has received to date in a single year. To date, the Committee for Medicinal Products for Human Use has given positive opinions for 28 biosimilars in the European Union.
Furthermore, the EMA and the European Commission (EC) released an information guide for healthcare professionals on biosimilar medicines in May 2017. The objective of the guide was to provide healthcare professionals with information on both the science and the regulation of biosimilar drugs.
“Promoting innovation and research in medicine development so that patients can benefit from much-needed safe, high-quality and effective medicines is a key priority for the Agency,” said the EMA in its report.
In the United States, the FDA more than doubled the number of drugs it approved in 2017, with 46 novel medicines receiving the green light compared with the year prior. However, it is important to note that the US drug approval tally for 2017 does not include the first of a new wave of cell and gene therapies from companies Novartis, Gilead Sciences, and Spark Therapeutics, which all had drug approvals in 2017 under a separate category.
Over the entire span of the biosimilar approval pathway’s use in the United States, the FDA has approved only 9 biosimilar therapies, with no approvals to date in 2018. In fact, the FDA has issued 4 Complete Response Letters (CRLs) in 2018: Celltrion received CRLs for both its proposed rituximab and trastuzumab biosimilars; Sandoz for its proposed rituximab biosimilar; and Pfizer for its proposed trastuzumab biosimilar.