Current European biosimilars market may suggest US threat to biotech will be limited

Biosimilars/News | Posted 14/09/2009

Though the threat of biosimilars is a hot topic in the US biotech market, their introduction in Europe may reveal that their effects will be limited.

Dutch health insurers obtain biosimilars green light

Biosimilars/News | Posted 14/09/2009

Health insurers in The Netherlands are allowed to include biosimilars in their preference policies, the Dutch health ministry has confirmed for the first time, signalling Europe's growing acceptance of these products.

Biotech drugs need adequate patent protection

Biosimilars/News | Posted 14/09/2009

The US government could establish “a properly constructed biosimilars pathway” by providing original developers of biotech drugs with at least 12 years of intellectual property protection to allow them to recover their investments in such treatments, writes former Vermont Governor, Mr Howard Dean, in his commentary. Two bills for follow-on biologics introduced in the House and Senate "include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments – and even cures – to patients around the world," Mr Dean writes.

Europe is biosimilar testing ground, but US will be key market

Biosimilars/News | Posted 07/09/2009

As the Federal Trade Commission weighs into the biosimilars debate in the US and the Obama administration considers seven years of market exclusivity enough for brand biologicals, new research by independent market analyst Datamonitor predicts that the success of the emerging biosimilars industry hinges on access to this market. With Japan receiving approval for its first biosimilar and the US moving ever closer to the establishment of an approval pathway, the biosimilars market is set for imminent expansion.

Biocon and Mylan join forces in biosimilars

Biosimilars/News | Posted 04/09/2009

Strong growth prospects for the global biosimilars space over the next decade are bringing together the world's third-largest US-based generic drugmaker Mylan and Biocon, India's second-largest biotech company.

US: Biotech drugs need only seven years protection

Biosimilars/News | Posted 04/09/2009

Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.

Sandoz receives approval for first-ever Japanese biosimilar

Biosimilars/News | Posted 04/09/2009

Sandoz has received marketing authorisation for the first ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.

KBI BioPharma starts US PER.C6 cell line generation service

Biosimilars/News | Posted 04/09/2009

US contract services firm KBI Biopharma announced on 25 June 2009 that it has started using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services, whether they are to produce biologicals, biosimilars or vaccines.

BIO wants to delay biodissimilars as long as possible

Biosimilars/News | Posted 31/08/2009

Biotech drugs are big revenue earners. Their sales growth rate may have slipped back into single figures last year, but according to IMS Health data they still accounted for more than 37% of the growth in the US pharmaceutical market last year, with revenues of around US$85 billion (Euros 60.8 billion), and biotech stands to take an even larger share of the market in future.

Obama wants to introduce US biosimilars pathway

Biosimilars/News | Posted 31/08/2009

US President Barack Obama plans to fund part of his healthcare reform plans by backing an approval pathway for generic biologicals. As reported by Christopher Spillane in Scrip News, Mr Obama lobbied the American Medical Association to support proposals to overhaul US healthcare in a far-reaching address.