Content about Biosimilar

December 23, 2011

Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

PHILADELPHIA — Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

The report, titled "The Changing Role of Chemistry in Drug Discovery" and based on drug industry productivity, patent data and other dynamics and trends, was released in recognition of the International Year of Chemistry 2011.

December 20, 2011

Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

PARSIPPANY, N.J. — Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

November 17, 2011

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.

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.

October 31, 2011

Watson Pharmaceuticals and a partnering company are barred from launching a generic version of a blood-thinning drug under a federal court decision issued Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals and a partnering company are barred from launching a generic version of a blood-thinning drug under a federal court decision issued Friday.

September 12, 2011

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.

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.


September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.

August 18, 2011

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.

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.

June 20, 2011

The overall growth in drug spending for 2010 was 3.7%, according to the latest drug trend report by pharmacy benefit manager Medco Health Solutions. The lower increase 
was primarily due to higher rates of generic drug dispensing — more than 71% of drugs dispensed were generics. 


June 13, 2011

Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

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.

May 18, 2011

Global spending on medicines will reach nearly $1.1 trillion by 2015, according to a new study by market research firm IMS Health.

PARSIPPANY, N.J. — Global spending on medicines will reach nearly $1.1 trillion by 2015, according to a new study by market research firm IMS Health.

May 13, 2011

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.

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)

May 9, 2011

The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.

In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.

May 4, 2011

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

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.

March 29, 2011

Any manufacturer that has the necessary resources and still is hesitating about whether to tap into biosimilars might want to go ahead and do it, if projections by British market analysis firm Datamonitor come true.

LONDON — Any manufacturer that has the necessary resources and still is hesitating about whether to tap into biosimilars might want to go ahead and do it, if projections by British market analysis firm Datamonitor come true.

The firm released a report Monday showing that the global biosimilars market, whose value stood at $243 million in 2010, will increase to $3.7 billion by 2015.

February 18, 2011

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.


February 17, 2011

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

February 14, 2011

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

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.

February 9, 2011

Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

February 1, 2011

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.


February 1, 2011

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.


January 18, 2011

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.

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.

January 12, 2011

Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

January 6, 2011

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

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.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

CAMBRIDGE, Mass. — Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.