The approval of the first two biosimilar drugs in the European Union is something to celebrate, according to the European Generic Medicines Association, but it is concerned by "an effort to multiply the number of unnecessary barriers that must be hurdled" that could jeopardise access to these medicines.
The approval of two human growth hormone products – Sandoz’ Omnitrope and BioPartners’ Valtropin – was given on the grounds that they match the reference medicine (Pfizer’s Genotropin) in quality, safety and effectiveness.
But Greg Perry, Direct General of the EGA, believes there are a number of developments that could inhibit the development of the biosimilar market, denying lower-cost versions of important biologic drugs to patients and healthcare systems.
One concern is a delay in the review of World Health Organisation guidelines on the naming of proteins, which is creating confusion over naming conventions, according to the EGA.
The trade body is concerned that the European Medicines Agency will refuse to give biosimilars the same generic name as the original product, as occurs with conventional generic drugs, "despite precedent and sound science confirming that this is the correct path to take."
But companies who developed the reference products believe because it is impossible to show that a biosimilar is truly identical, they should be prohibited from having the same generic name as the originator product.
Innovator companies, claims the EGA, are also trying to make it necessary for biosimilars to use ramped-up traceability and monitoring procedures, often on the grounds that it is important to be able to identify the exact product given to a patient if side effects occur. But the EGA maintains biosimilars should be treated in the same way as other biologics. Otherwise, the cost of delivering these products to market will escalate.
As it stands, the high cost of manufacturing biologic drugs means that developing biosimilars could be a risky business, according to industry observers.
Stephen Charles of drug delivery company Nektar Therapeutics, which works with Amgen to develop long-acting versions of its biologic drugs, has estimated that a biosimilar will require a development programme of at least $50 million, which could make the return on investment unattractive for companies developing biosimilars unless they price them at or near their reference counterparts.
Meanwhile, the EGA is also concerned that the hurdles of pricing approval, reimbursement status and substitutability might be raised higher for biosimilars than those currently in place for generics, "despite the clear statements of therapeutic equivalence in the assessment reports (EPARS) for biosimilars."