Content about Biotechnology

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

ROCKVILLE, Md. Human Genome Sciences and Novartis have decided not to further develop an investigative biologic treatment for hepatitis C following the Food and Drug Administration’s decision to decline its approval, HGS said Tuesday.

HGS said it received a complete response letter from the FDA concerning the drug Zalbin (albinterferon alfa-2b). The FDA delivers a complete response letter to indicate that it has finished reviewing an application, but questions remain that preclude final approval.

BURLINGTON, Mass. The drug market for Crohn's disease treatments will see moderate growth over the next decade, Decision Resources reported Wednesday.

The research firm projected that the market will increase a little more than 31%, from $3.2 billion in 2009 to $4.2 billion in 2019, in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Decision Resources said the the modest growth rate masks such market changes as new and emerging biologics, as well as generic competition.

CHADDS FORD, Pa. Endo Pharmaceuticals will acquire generic drug maker Qualitest Pharmaceuticals for $1.2 billion, Endo said Tuesday.

Endo said the purchase of privately owned Qualitest would expand its offering of branded drugs, generics, devices and services in areas such as pain and urology. Qualitest is the sixth largest generic drug company in the United States, as measured by prescriptions filled.

PEAPACK, N.J. —The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone announced the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.

LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.

Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.

SOMERSET, N.J. A lot of generic drug companies have conducted business in the branded drug market on the side for a long time, with Teva Pharmaceutical Industries and Watson Pharmaceuticals standing out as good examples. But lately, some branded drug companies have sought to get into generics as well.

Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda A.B., recently decided to create its own generics subsidiary, calling it Wallace Pharmaceuticals, senior marketing director John White told Drug Store News.