The EU has recently finalised its policy and legal framework for so-called biosimilars, opening the EU market for generic versions of biotechnology-derived drugs. The first such drug is about to enter the EU market.
The European Medicines Agency (EMEA) adopted its first ever positive opinion for a similar biological medicinal product in January 2006. The product, Omnitrope, contains growth hormone and is intended for the treatment of growth disturbance in children and adults. It is manufactured by the Swiss drugmaker Novartis AG‘s generics unit Sandoz GmbH and, according to EMEA’s studies, demonstrated comparable quality, safety and efficiency as the reference medicinal product Genotropin, which is manufactured by Pfizer.
Omnitrope was given market authorisation, by the Commission, on 20 April 2006.
The EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, can lead to a competitive advantage to the EU biosimilars industry.
According to Commissionner Günter Verheugen, biosimilar medicines offer new opportunities "for the control of national healthcare expenditure".
“As more biotechnology-based products come off patent, biosimilars will play an increasingly important role by providing lowercost, safe and effective versions of patent-expired biological medicines,” said the CEO of Sandoz, Dr. Andreas Rummelt. With marketing authorisation granted in Europe, Sandoz now hopes that the US Food and Drug Administration (FDA) will act to approve Omnitrope in the US.
European Generic Medicines Agency (EGA) has welcomed the new legal framework and thinks that the EU is now set to become "the global centre for R&D and production of this new generation of affordable, biotech pharmaceuticals, giving the EU a huge competitive advantage over other countries like the United States and Japan".
"From the point of vew of innovation and stimulating R&D on the sector, having a legal framework for biosimilars is not necessarily a good thing, as it allows maket to 'copy' existing drugs," said the chairman of EuropaBio's biosimilar medicinal products working group, Tom Bols.
The current EU-framework does not address labelling of biosimilars. EuropaBio points to this as an outstanding issue and highlights the need for a unique name and label for a biosimilar: "Clear and distinct labelling is essential to avoid confusion between the innovator product and a biosimilar and to facilitate pharmacovigilance obligations."
All medicines enjoy a 20-year patent. After the expiry of the patent, other companies are allowed to develop and manufacture these medicines. Patent and data protection for the first bio-pharmaceuticals have just expired or are about to expire in Europe. This opens the market for new generic 'copies' of these products, referred to as biosimilars.
Until recently no legal framework existed for generic medicines derived from biotechnology. This issue was tackled in the review of EU pharmaceutical legislation ('Pharma Review 2001'), in which specific provisions establish the legal base for biogenerics, now called similar biological medicinal products. The general regulatory guideline for evaluating and approving similar biological medicinal products was to be transposed by member states before 30 October 2005.
The EU framework for biogenerics is, therefore, now in place. Once the patents and data exclusivity on the original bio-pharmaceutical product expire, selected biosimilar medicines can be launched on the European market after appropriate testing to confirm their safety, quality and efficacy. This will end big drugmakers' monopoly in bio-pharmaceuticals and could lower prices for biotech medicines due to market competition.
- Sandoz expects to begin marketing Omnitrope soon after negotiations with government health authorities regarding pricing and other regulatory requirements.
- First EU markets to welcome Omnitrope will be Germany and Austria.
EU official documents
- Commission press release:Biotech medicines: first biosimilar drug on EU market(20 April 2006) [FR] [FR] [DE]
- European Medicines Agency press release:European Medicines Agency adopts first positive opinion for a similar biological medicinal product(27 January 2006)
- European Medicines Agency:Biosimilar medicinal products - Adopted Guidelines
- European Medicines Agency:Guideline on similar biological medicinal products(30 October 2005)
Business & Industry
- Sandoz press release:Sandoz Receives European Commission Marketing Authorization for Omnitrope®(18 April 2006)
- EuropaBio fact sheet:Biological and Biosimilar Medicines
- Emerging Biopharmaceutical Enterprises (EBE):Biosimilars
- EuropaBio:Biosimilar Medicinal Products working group
- European Generic Medicines Agency (EGA):Biogenerics - Legal & Regulatory Framework ; Comparability Guidelines ; Scientific Articles & Presentations
- European Generic Medicines Agency (EGA):FAQ on biosimilar medicinal products
- European Generic Medicines Agency (EGA):Biogenerics
- Newark Star Ledger (USA):Europe OKs generic biologic
- Boursier.com:Novartis : feu vert européen à la vente d'Omnitrope par Sandoz
- Frankfurter Allgemeine Zeitung:EU lässt "Omnitrope" der Novartis-Tochter Sandoz zu
- Hogan & Hartson L.L.P. :EU Moves Closer to a “Biosimilar” Approval: What This Means for the EU and U.S. Markets(February 2006)