Home / Biosimilars / News


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.

AutekBio to build ‘Asia’s largest biologics contract manufacturing organisation’ in China

AutekBio, Inc. –with headquarters in the Bay Area of California, USA, but operations in China– will build one of Asia’s largest biologic contract manufacturing organisation (CMO) facilities in southern Beijing, China. To construct the facility, AutekBio signed a deal securing US$100 million in venture capital from private and government sources. Contributing to the capital raise were SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, Beijing’s Municipal Government’s venture capital group. The new joint venture will build a world class R & D and manufacturing centre in southern Beijing, to service international biologic developments, with combined volumes of bioreactors up to 20,000 L in multiple production lines (trains).

Modern monoclonal antibody production - focus on quality by design, timelines, cost

In the decade since severe capacity constraints limited monoclonal antibody (MAb) production, the industry has adjusted, so that today, overcapacity is the issue, along with developing techniques to ensure product quality, reduce development timelines, and decrease costs, writes Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010. Many of these issues will be explored at IBC’s conference on ‘Antibody Development and Production’ in March 2010 as she points out.

How to tackle overcapacity in monoclonal antibody production

In the early days, most monoclonal antibody (MAb) therapies required high dosages, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also Monoclonal antibodies modelling - predictive analytics, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)