Content about Biosimilar

MOUNTAIN VIEW, Calif. — The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

It’s hard to disagree that generic drug companies have had a good run for the last several years. Branded drug companies developed a large number of drugs that proved highly effective at treating widespread medical conditions and became blockbusters, garnering billions of dollars in sales in the United States alone. As patents on these blockbuster drugs have expired, they’ve provided generic manufacturers with enormous revenues, helping some to join the ranks of the world’s biggest drug companies.


DANBURY, Conn. — With the global biosimilars market expected to expand nearly sixfold by the middle of the decade, market research firm IMS Health is launching a market-measurement tool for drug makers interested in getting into the space, the company said.

WHITEHOUSE STATION, N.J. — Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

Merck, which operates outside the United States and Canada as MSD to avoid confusion with Germany-based Merck KGaA, announced Monday a collaboration with Seoul, South Korea-based Hanwha Chemical to develop and commercialize HD203, a biosimilar version of Enbrel (etanercept), made by Amgen and Pfizer. The drug is used to treat such disorders as rheumatoid arthritis and psoriasis.

WHAT IT MEANS AND WHY IT’S IMPORTANT — The Generic Pharmaceutical Association and other trade and patient advocacy groups can push generic drug usage as a way to save on medical costs, but throwing the weight of Congress behind generics gives them a bigger boost than ever.

(THE NEWS: GPhA expresses support of Congressional Affordable Medicines Caucus. For the full story, click here)

NEW YORK — Novartis is making big investments in biosimilars, CEO Joe Jimenez said in an interview with Fortune magazine.

Jimenez told Fortune that the Swiss drug maker — which markets generics and biosimilars through its Sandoz division — was investing heavily in biosimilars and difficult-to-make generics for such conditions as cancer and respiratory disorders.

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.