12 years exclusivity workable for patients; not anticompetitive

Biosimilars/General | Posted 26/01/2010

On Gene Quinn distinguishes facts from fiction about biosimilars.

Minimal 12 years of biologicals data exclusivity required

Biosimilars/News | Posted 26/01/2010

As reported by Gene Quinn on, for many months we have been hearing about the US government attempts to “reform” health care in the United States.

Teva seeks closer ties with Lonza on biosimilars

Biosimilars/News | Posted 25/01/2010

Biogenerics is a field that is becoming more and more important to Teva and the company seeks to deepen its existing ties in this area with Swiss company Lonza. Sources inform Globes that Teva President and CEO, Shlomo Yanay, CFO Eyal Desheh, and all the company’s board, flew to Switzerland for two days of meetings intended to extend the collaboration between the two companies.

Pfizer’s biosimilars strategy

Biosimilars/News | Posted 22/01/2010

“I think it is a good strategy for a large company like Pfizer that wants to be a player in generics”, Ronny Gal, a Sanford C Bernstein Analyst in New York said. “I would be surprised if they weren’t considering biogenerics”.

Is US Congress poised to hinder biosimilars market entry?

Biosimilars/General | Posted 19/01/2010

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik. Ms Eshoo said her proposal would give original makers of biotech drugs adequate profit to discover new treatments without discouraging generic drugmakers from working on follow-on biologics.

Dr Stephen Sherwin: Biosimilars pathway with 12 to14 years of biologics exclusivity

Biosimilars/News | Posted 14/01/2010

BIO SmartBrief Editor Ashley McMaster, corresponded with Ceregene co-Founder/Chairman and BIO Board Chair Dr Stephen Sherwin to get his thoughts on what direction the biotechnology industry is headed in 2010.

Teva submits BLA for biosimilar filgrastim in US

Biosimilars/News | Posted 08/01/2010

Teva has taken its first step in the US biosimilars market. On 1 December 2009 the company submitted a Biologics License Application (BLA) with the US FDA for XM02, a biosimilar filgrastim for the treatment of severe neutropenia, a blood disorder characterised by an abnormally low number of neutrophils, the most important type of white blood cells in the blood.

Biosimilar EPO, vildagliptin and liraglutide among latest Japanese recommendations

Biosimilars/News | Posted 21/12/2009

The latest batch of positive product recommendations in Japan includes a biosimilar erythropoietin (EPO) and two novel antidiabetics, Novartis’s DPP-4 inhibitor Equa (vildagliptin) and Novo Nordisk’s GLP-1 analogue Victoza (liraglutide).

Market protection for biologicals should be less than 12 years

Biosimilars/News | Posted 18/12/2009

Giving 12 years of market protection to brand-name biopharmaceuticals would add to mounting pressure on healthcare costs and deprive patients of affordable follow-on biologics for many years, according to an editorial in The Boston Globe. It says US Congress should enact a law that provides exclusivity for more than five years but fewer than 12 to balance innovation and affordability of biotech drugs.

US bill would add six months' protection for biotech drugs

Biosimilars/News | Posted 15/12/2009

A US healthcare reform bill introduced by Senate Majority Leader Harry Reid would extend the protection some brand-name biotech medicines would get from their generic counterparts by six months. An industry executive said this would provide an incentive for companies to make products for children.