Content about Biologic

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 10, 2011

The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

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.

March 31, 2011

The Healthcare Distribution Management Association on Tuesday honored Rep. John Shimkus, R-Ill., with its Rx Safety and Healthcare Leadership Award.

ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday honored Rep. John Shimkus, R-Ill., with its Rx Safety and Healthcare Leadership Award. The award recognizes public officials for their leadership and commitment to policies that support and promote the safe and efficient delivery of medicines.

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.

March 3, 2011

The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

WASHINGTON — The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

The Pharmaceutical Care Management Association announced Thursday that president and CEO Mark Merritt had received the GPhA’s Outstanding Contribution Award at the generic drug industry group’s annual meeting in Orlando, Fla. The organization has advocated increased generic drug utilization and found common cause with the generics industry in its support for follow-on biologics.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.

February 25, 2011

Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

EAST BRUNSWICK, N.J. — Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

The drug maker announced the U.S. commercial launch of Krystexxa (pegloticase).

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 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 3, 2011

The former top executive of the Generic Pharmaceutical Association may have gone to work for the National Community Pharmacists Association, but the generic drug industry trade group got one of the independent pharmacy group’s executives as well.

WASHINGTON — The former top executive of the Generic Pharmaceutical Association may have gone to work for the National Community Pharmacists Association, but the generic drug industry trade group got one of the independent pharmacy group’s executives as well.

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

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 10, 2011

PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

BOISE, Idaho — PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

PakSense said its BIOmed Label is about the size of a sugar packet and can be used to digitally monitor the temperatures of pharmaceuticals, biologics and vaccines during storage and distribution.

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 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.

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.

November 30, 2010

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

 

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

 

 

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.