Spectrum to develop biosimilar monoclonal antibody

Biosimilars/News | Posted 04/03/2011

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).

Biosimilars boost for South Korea

Biosimilars/News | Posted 25/02/2011

The South Korean Government has pledged to promote the biosimilars industry and plans to invest in the biosimilars industry in order to make Korea a market leader. The government will provide both financial and institutional support and is aiming to take a 22% share of the global market by 2020.

Gedeon Richter sign biosimilars’ agreement with Mochida

Biosimilars/News | Posted 11/02/2011

On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and collaboration agreement with respect to development and marketing of Richter’s biosimilar product portfolio.

Sandoz announces biosimilar rituximab

Biosimilars/News | Posted 21/01/2011

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

Biosimilars/News | Posted 10/12/2010

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

Biosimilars/News | Posted 08/11/2010

Biocon, India’s largest biotechnology company by revenue and Pfizerthe world’s biggest pharma companyannounced 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

Biosimilars/News | Posted 29/10/2010

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)

Biosimilars/News | Posted 20/10/2010

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

Biosimilars/News | Posted 08/10/2010

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

Biosimilars/News | Posted 17/09/2010

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.