Biosimilars/News

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.

Top 10 blockbuster biotech drugs: next biosimilar targets?

Biosimilars/News | Posted 02/12/2009

FierceBiotech’s Top 10 Blockbuster Biologics may be future biosimilar targets:

It may take four to five years before the first US biosimilar is a fact

Biosimilars/News | Posted 01/12/2009

It may take about four to five years for a biogeneric drug to hit the US market, even though industry experts are optimistic about the passage of pending healthcare reform legislation there by the end of 2009.

Partnering better for biosimilars, limited growth in generics will lead to moves for innovative drugs

Biosimilars/News | Posted 26/11/2009

With six biosimilar compounds in the works and two launched in the Indian market, India's second largest generic drug maker – Dr Reddy's Laboratories – is negotiating with several multinational companies to broaden its presence in Western markets. The unveiling of a deal that may span from sharing regulatory and manufacturing expertise to distribution and detailing could be expected some time next year (in 2010). But the task of taking biosimilar drugs into developed markets will be tough and expensive as regulatory agencies will likely seek submissions on non-inferiority clinical trials that will be large-scale, typically involving close to a thousand patients or even more.

Patient safety should be addressed in biosimilars measure

Biosimilars/News | Posted 26/11/2009

US Congress should ensure that patient safety and medical efficacy are prioritised in a healthcare-reform measure that allows the use of follow-on biologics (or FOBs) according to David Nash of the Jefferson School of Population Health. Rather than just debating data exclusivity for follow-on biologics, lawmakers should also specify rules on testing these drugs and consider requiring post-market surveillance to avoid ‘unintended consequences’ that compromise patient safety, he writes.

Delaware and BIO advocate call for biosimilar support

Biosimilars/News | Posted 25/11/2009

In a DelawareOnline Letter to the Editor of 2 November 2009, Delaware BioScience Association President Bob Dayton and Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood called on Delaware's lawmakers to protect consumer safety and ensure innovation of biosimilars as US Congress works on healthcare reform legislation.

Biotech drugmakers get 12-year protection in US House health bill

Biosimilars/News | Posted 19/11/2009

The US House health reform bill unveiled on 29 October 2009 would grant brand-name biotech-drug manufacturers 12 years of exclusivity before generic versions of their products can rely on their safety and efficacy data. The bill also would require drugmakers to pay an estimated US$60 billion (Euros 40.13 billion) in Medicare reimbursements over the next 10 years and allow the federal government to negotiate prices directly with companies.

Mycenax to start phase III etanercept biosimilar trial

Biosimilars/News | Posted 17/11/2009

Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully completed a phase I trial in South Korea and a phase I/II clinical trial in Taiwan is in the data analysis and report preparation stage; important clinical trial milestones towards the commercial release of the drug in both regional and global markets.

Merck & Co uses its traditional strengths in biosimilars race

Biosimilars/News | Posted 16/11/2009

With sales growth for biologicals expected to outpace that in the overall pharmaceutical sector over the next few years, it is not surprising that ‘big pharma’ has been beefing up its presence in the sector through acquisitions and licensing deals.