Biosimilars/News
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).
Cipla enters the biosimilars market
India-based generics’ manufacturer Cipla is paying US$65 million to buy a significant minority stake in two Asian biotech companies with plans to develop a range of discounted biosimilars, generic substitutable versions of branded biologic drugs. Cipla's Chairman says he specifically wants to create follow-on therapies to three of Roche's top biologics – Avastin, Enbrel and Herceptin – that account annually for US$19 billion in sales.
Hospira’s biosimilar filgrastim product Nivestim approved
On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for the prevention of febrile neutropenia and reduction in duration of chemotherapy-induced neutropenia.
Development of a new biosimilar filgrastim product (Zarzio)
Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially in patients with neutropenia (low white blood cell count in the blood), causing reduced host defence.
Health Canada issues finalised guidance on biosimilars
Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEBs), which is effective as of 5 March 2010.
