Biosimilars bill passed by House committee draws response from GPhA
NEW YORK A House committee vote has brought a pathway for biosimilars one step closer to reality, but not in a way that pleases everyone.
The House Energy and Commerce Committee voted 47-11 Friday to pass an amendment to the healthcare reform bill that would give biotech drugs 12 years of market exclusivity before they face competition from biosimilars.
“We are sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger said in a statement. “The amendment passed tosses patient needs out the window.”
In March, Reps. Henry Waxman and Anna Eshoo, both California Democrats, sponsored competing bills in Congress to allow a regulatory pathway for biosimilars. Waxman’s bill would give biotech drugs five years’ market exclusivity before facing biosimilar competition, like the Hatch-Waxman Act of 1984, which created a pathway for generic pharmaceutical drugs. Eshoo’s bill would grant 12 to 14 years of exclusivity. The short-exclusivity plan has the support of the generic drug industry, patient advocates, pharmacy trade groups and The Washington Post editorial page, though legislation to allow longer exclusivity periods has advanced further in the House and Senate.
GSK: Rheumatoid arthritis treatment meets trial goals
LONDON A late-stage clinical trial of a biotech drug for rheumatoid arthritis has met its goals, the drug’s developers announced Wednesday.
British drug maker GlaxoSmithKline and Danish drug maker Genmab announced that patients in a phase 3 trial taking ofatumumab experienced a 20% improvement in the number of swollen and tender joints, as the companies expected.
In the 260-patient study, the 129 patients taking ofatumumab had a 50% response rate, compared to 27% of those taking placebo. The companies also said there were no unexpected safety problems, but 5% of patients experienced rash, hives, throat irritation and other side effects.
“We have always believed in ofatumumab’s potential to make a difference in patients’ lives,” Genmab CEO Lisa Drakeman said in a statement. “We are pleased with the results of this study, supporting the further investigation of this antibody’s promise in the treatment of RA.”
Medarex reports narrowed loss, nearly doubled revenue for Q2
PRINCETON, N.J. Biotech drug maker Medarex reported a less severe drop in second-quarter loss, while its revenue almost doubled from last year.
The Princeton, N.J.-based Medarex reported losses of $29.2 million compared with a loss of $53.1 million in the same quarter last year.
This year’s revenue was up 96% from last year’s $10 million to $19.5 million.
New York-based Bristol-Myers Squibb, the maker of blood thinner Plavix, put forth $2.1 billion to acquire Medarex.