by Richard Staines
LONDON, Jan 12 (APM) - Approval of a first biosimilar in the U.S. would be “huge” for EU generics firms as it will promote co-operation and save regulatory costs on both sides of the Atlantic, an industry trade body told APM.
Adrian van den Hoven, director general of the European Generic Medicines Association (EGA), on Friday said the possible approval of Sandoz’s Zarxio (filgrastim) biosimilar will encourage joint working between the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on biosimilars.
An approved biosimilar in the U.S. came a step closer last week after advisers to the FDA recommended Zarxio (APMMA 41031), although the regulator is not bound by the decision.
Biosimilars are particularly important to generics firms as prices for small molecule generic pills such as statins are under intense pressure (APMMA 41056), with some countries such as France cutting prices and volumes, the EGA said.
Van den Hoven said biosimilar development costs could fall if the U.S. begins approving more biosimilars and the two regulators learn to pool data and reduce the number of clinical trials necessary for approval.
This so-called “single development” pathway is a priority for the EGA as it seeks to reduce costs by eliminating duplication of regulatory work on either side of the Atlantic.
“It is positive in terms of co-operation between the EU and the U.S. As the FDA develops its experience in approving biosimilars, I think they will develop that trust in working with the EMA.
“They already share confidential information and we think it is important to stimulate co-operation between FDA, the EMA and the European Commission. Single development will lower the overall costs of bringing the products to market and mean the costs of medicines are lower.”
The EMA last year formalised a process allowing approvals from reference products in the U.S., while the FDA can also use data from EU products under established guidance (APMMA 40289).
Van den Hoven made his comments as the industry prepares for the launch of the first biosimilar monoclonal antibody in western Europe - Celltrion/Hospira’s biosimilar of Johnson & Johnson/Merck, Sharp and Dohme’s Remicade (infliximab) for autoimmune disorders.
Called Remsima when marketed by Celltrion and Inflectra when sold by Hospira, the biosimilar is set for launch next month (APMMA 37915).
“We know other monoclonal biosimilars are on their way. This will be an important milestone.”
The main challenge for industry in Europe is raising awareness about biosimilars with prescribers, pharmacists and health organisations so they feel comfortable using them, said van den Hoven.
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