Content about Biologic

May 11, 2012

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 9, 2012

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

January 20, 2012

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


January 3, 2012

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

December 23, 2011

Baxter and Momenta have agreed to partner to develop and market biosimilar drugs to treat cancer, autoimmune disorders and other chronic conditions.

NEW YORK — Baxter and Momenta have agreed to partner to develop and market biosimilar  drugs to treat cancer, autoimmune disorders and other chronic conditions.

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.

November 4, 2011

The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

November 4, 2011

In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010.

In September, the Generic Pharmaceutical Association announced the appointment of Ralph Neas — former president and CEO of the National Coalition on Health Care — as its new president and CEO, replacing Kathleen Jaeger, who stepped down as president and CEO of the organization in May 2010. Drug Store News recently spoke with Neas about his plans and vision for the organization and the industry as a whole.


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.

October 19, 2011

PakSense has launched a new label that monitors time and temperature of such perishable items as food, vaccines, pharmaceuticals and biologics during distribution and storage.

BOISE, Idaho — PakSense has launched a new label that monitors time and temperature of such perishable items as food, vaccines, pharmaceuticals and biologics during distribution and storage.

September 22, 2011

Two drug makers have entered a collaboration for novel biologics programs in diabetes and heart failure.

PRINCETON, N.J., and LA JOLLA, Calif. — Two drug makers have entered a collaboration for novel biologics programs in diabetes and heart failure.

Under the partnership, Bristol-Myers Squibb will receive exclusive worldwide rights to research, develop and commercialize biologics, based on research by Ambrx of fibroblast growth factor 21 (FGF-21) protein and relaxin hormone, which potentially can treat Type 2 diabetes and heart failure, respectively.

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 12, 2011

The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

The FDA said it would rename the Office of Oncology Products the Office of Hematology and Oncology Products. The office, which is responsible for reviewing regulatory applications for pharmaceutical and biotech drugs for cancer, is overseen by the Center for Drug Evaluation and Research. Office of Oncology Products director Richard Pazdur will continue as director of the OHOP.

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.

August 1, 2011

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.

June 28, 2011

Eli Lilly will invest funds into its existing biotechnology capabilities to further research and development of multispecific therapeutics.

WASHINGTON — Eli Lilly will invest funds into its existing biotechnology capabilities to further research and development of multispecific therapeutics.

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 14, 2011

The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

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)