Biosimilars
US bill would add six months' protection for biotech drugs
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.
US Senate healthcare bill preserves biologicals exclusivity, but charges annual drugmaker fees
The recently released US Patient Protection and Affordable Care Act, H.R. 3590, will ensure that all Americans have access to quality, affordable health care and will create the transformation within the healthcare system necessary to contain costs.
Top 10 blockbuster biotech drugs: next biosimilar targets?
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
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.
Patient safety should be addressed in biosimilars measure
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.
Partnering better for biosimilars, limited growth in generics will lead to moves for innovative drugs
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.
Delaware and BIO advocate call for biosimilar support
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.
Dingermann: “Use biosimilars, but don’t force patients”
“Thanks to the stringent examinations of EMEA, patients can trust that approved biosimilars are effective and tolerable – a reassuring remark for those who are dependent on such medicines,” said Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ;Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.
Why is “the process the product” for biosimilars?
“Why does the manufacturing process play such a prominent role in the definition of a biosimilar?” asked Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ‘Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.
Why are there suddenly ‘biosimilars’ besides ‘biologicals’?
“Isn’t everything already complicated enough?” asked Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ‘Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.
