Biosimilars
The hurdles to biosimilars in Europe
The stage is set for the entrance of biosimilars into the healthcare market. Patents are near expiry on the first biopharmaceuticals and the global biosimilars market is predicted to be worth more than Euros 1.5 billion by 2015. However, development costs will be high, unlike with generic drugs, the time taken to develop biosimilars is long, and acceptance on the market is not guaranteed.
Biosimilar EPOs show the same or better quality
Researchers have found biosimilar erythropoietin (EPO) products have the same or even better quality compared with the original branded products.
Hurdles to biosimilars in Asia
Now that a clear regulatory pathway for marketing biosimilars has been established in Europe, will Asian companies enter the global biosimilars race? Asian manufacturers face the same obstacles as western-based drugs companies, but local factors add a further twist to the tale.
Pfizer and India-based Biocon make biosimilar insulin deal
Biocon, India’s largest biotechnology company by revenue and Pfizer—the world’s biggest pharma company—announced on 18 October 2010 that they have entered into a strategic global agreement for the worldwide commercialisation of Biocon's biosimilar versions of insulin and insulin analogs (recombinant human insulin, glargine, aspart and lispro).
Hurdles to entering the biosimilars’ market
Yet more hurdles to entering the biosimilars’ market have been identified in a Reuters’ report. High development costs, complex manufacturing and legal hurdles are holding back generic drugmakers seeking to copy high cost biotech medications nearing the end of their patents.
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.
