Biosimilars/News
Sandoz announces biosimilar rituximab
Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced on 10 January 2011 a phase II clinical trial for a biosimilar version of leading monoclonal antibody rituximab.
Contract manufacturing: top firms are investing
Lonza Group Ltd and ScinoPharm Taiwan Ltd, two leading manufacturers of active pharmaceutical ingredients (APIs), have struck separate deals to expand their capabilities to make biological drugs.
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).
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.
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.
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.
FDA approves first biosimilar enoxaparin sodium
On 23 July 2010, Momenta Pharmaceuticals and Sandoz announced that they had received approval from the FDA for their biosimilar version of sanofi-aventis’s (sanofi-aventis’s ) blockbuster blood thinning drug, Lovenox (enoxaparin sodium).
