Latest News – Page 50 – Safe Biologics

The Alliance for Safe Biologic Medicines Statement on the Need for Unique Names for All Biologic Medicines

September 20, 2013

WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars. “Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. […]

The Alliance for Safe Biologic Medicines Statement on the Need for Unique Names for All Biologic Medicines

September 20, 2013

WASHINGTON, DC – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., added a physician’s perspective to the ongoing discussion around the naming of biologic medicines, including biosimilars. “Biologics are highly sensitive to the manufacturing process and their environment; slight differences can have unexpected results,” stated Dolinar. “As a physician, patient safety is paramount. […]

American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars. The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.

American Academy of Dermatology Updates Biosimilar Statement

August 15, 2013

This month, the AADA’s Board of Directors approved an updated version of their position statement on biosimilars. The AADA specifically adds new language to clarify physician notification by pharmacists. Read full statement here.

Article in GEN Insight & Intelligence: Latest Biosimilar Guidance Raises More Questions. Quick FDA action just as unlikely as last year, when agency issued original policy advice.

July 9, 2013

Testifying before Congress in April, FDA Commissioner Margaret A. Hamburg, M.D., sought to reassure lawmakers: “We are developing a science-based process for bringing safe and effective biosimilar and interchangeable products to market, which should increase competition and create substantial savings for patients, healthcare providers, and insurers.” More than a year after issuing three draft guidances […]

Dolinar Adds to the Emerging Consensus Among Stakeholders on the Need for Unique Names at an International Regulator Forum

July 1, 2013

Ottawa, ONTARIO – Alliance for Safe Biologic Medicines (ASBM) chairman, Richard Dolinar M.D., was one of a small group of patient advocates invited to address international regulators at the “Regulator Forum on Biologic Naming and Traceability” hosted by Health Canada and BIOTECanada on June 26 and 27. Dolinar’s presentation added a physician’s perspective to the […]

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership. EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio […]

EuropaBio joins the Alliance for Safe Biologic Medicines

June 27, 2013

WASHINGTON, DC- The Alliance for Safe Biologic Medicines (ASBM) is pleased to announce the addition of EuropaBio to its membership. EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 14 associate members and Bio […]

Quality, Manufacturing Transparency Key to Avoiding Biologic Drug Shortages: Dolinar Addresses 49th Annual DIA Conference

June 25, 2013

BOSTON, Mass. — Speaking at the 49th Annual Drug Information Association (DIA) Conference, Dr. Richard Dolinar, chairman of The Alliance for Safe Biologic Medicines (ASBM), presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dr. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality and consistency are vital for ensuring a steady and safe supply of biologic medicines for patients.

Baltimore Sun: In debate over ‘biosimilars,’ patient safety must come first

May 22, 2013

In 1988, I became extremely ill. I had many tests, saw many doctors and was given various medicines. Some caused allergic reactions. Through it all, I remained sick — and actually became worse. Eventually, I was diagnosed with autoimmune hepatitis, a very rare disorder. Much of the information I read said I had about 10 […]