Biosimilars
FDA holds public hearing on biosimilars pathway
The FDA has taken further steps towards implementing guidelines on the approval pathway for biosimilars in the US by holding a public meeting on the matter.
Delays in FDA approval of biosimilar G-CSF (filgrastim)
Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.
Australia approves first biosimilar filgrastim
On 26 September 2010 US-based generics manufacturer Hospira announced that it had received approval from the Therapeutic Goods Administration (Australia's regulatory agency for medical drugs and devices) for its biosimilar filgrastim product, Nivestim.
Epoetin alfa and pure red cell aplasia
Most therapeutic proteins have the potential to induce an immune response. Cases of pure red cell aplasia (PRCA) were reported after the formulation of Eprex (epoetin alfa) was changed. It is now known that ‘the process is the product’ and the formulation cannot be changed without approval by the relevant authorities.
Approval of biosimilar epoetins: how similar are they?
A consensus has emerged that approval of biosimilars requires both biological and clinical evidence. The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physico-chemical characterisation by several methods, comparative biological assays, comparative immunogenicity assessment, among others. The use of different host cells for the biosimilar product and the comparator in principle is possible.
Biosimilar epoetins: how similar are they?
As the patent expiry dates of the original erythropoietins drew near, much concern was expressed in 2004 about possible biosimilar competitors. Product quality, safety and efficacy of biopharmaceuticals are highly dependent on the processes of production, purification and formulation. How have these genuine concerns been answered by the EMA in granting marketing approval, and have any other problems come to light?
Cipla invests in biosimilars
India-based generics’ manufacturer Cipla is increasing its presence in the biosimilars’ market with major investments planned for the near future, according to a report in the Indian newspaper Business Standard.
Highs and lows for biosimilars during 2009/2010
A lot has happened in the biosimilars’ industry during 2009/2010.
Dr Reddy’s launches biosimilar Aranesp
Dr Reddy’s Laboratories increases its stake in the biosimilars’ market with the latest launch in India from its biosimilars’ programme. Cresp is the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Darbepoetin alfa is used for the treatment of anaemia due to chronic kidney disease and chemotherapy.
Good news for biosimilar enoxaparin sodium
French pharma giant sanofi-aventis (sanofi) has been denied a request to block sales of a generic version of its Lovenox blood thinner by a US district court.
