Biosimilars/News
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.
Ranbaxy to develop biosimilars with US-based Pfenex
On 29 March 2010, Daiichi Sankyo’s Ranbaxy Laboratories in India announced its collaboration with US-based Pfenex on the development of an undisclosed biosimilar therapeutic protein with the Pfenex Expression Technology platform, a Pseudomonas-based recombinant protein expression technology.
US healthcare reform passed: Biosimilars Pathway in US with 12 years exclusivity for biologics
The US House of Representatives voted 219-212 on March 21 2010 to approve President Mr Barack Obama’s US$940 billion, 10-year health reform, and he could now sign the bill into law as early as 23 March 2010.
Hospira's biosimilar filgrastim recommended for EU approval
On 18 March 2010, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for Hospira’s biosimilar product Nivestim (filgrastim), 12 MU/0.2 mL, 30 MU/0.5 mL, 48 MU/0.5 mL solution for injection or infusion intended for the treatment of neutropenia.
South Korea to emerge as global leader in biosimilar R & D
According to the South Korea Pharmaceuticals and Healthcare Report Q2 2010 released by Business Monitor International (BMI) in March 2010, South Korea will emerge as a global leader in biosimilar research and development.
