New biosimilar drug rules for implementation

[b]European regulators will detail the requirements for copies of multiple types of biotech drugs by mid-2012, setting the stage for increased generic competition in a multibillion-dollar market that includes products for cancer and modern insulins.

Guido Rasi, the new executive director of the European Medicines Agency (EMA), told Reuters on Friday the London-based watchdog would issue its final guideline on biosimilar monoclonal antibodies in March or April.

Draft guidelines on the approval process for copies of other drugs will follow in May or June. These will include low molecular weight heparin, such as Sanofi’s Lovenox or enoxaparin, and modern analogues of insulin.

Up to now, complex biotechnology medicines, which are given by injection, have been largely immune from generic competition, unlike conventional chemical pills and capsules.

But the regulatory landscape is starting to change, posing a threat to leading biotech companies.

Europe has already approved some so-called biosimilars, including copycat versions of human growth hormone and the anemia treatment EPO. Antibodies, however, are a much bigger prize, since they include blockbuster treatments for diseases such as cancer and rheumatoid arthritis.[/b]