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 […]

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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 […]

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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 […]

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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.

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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 […]

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Interview with Bloomberg BNA

May 16, 2013

Executive Director Michael Reilly spoke with Bloomberg BNA on the challenges facing the biosimilars process both in the U.S. and abroad. View the Video Insights interview here.

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Capitol Weekly (Sacramento): In search of affordable health care

April 26, 2013

By Gerald Felando Affordable, quality health care is a mainstay topic in today’s media and will continue to be, especially here in Sacramento. As a dentist, cancer survivor and former member of the California Assembly, I know the importance of creating policy that is patient-centered. The delivery of optimal health care for patients is constantly […]

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The Sun Sentinel: Low costs medicines could jeopardize patient health

April 26, 2013

In Florida’s House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today’s most-advanced medicines. Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It’s critical for lawmakers to revert to their original proposal. The legislation under consideration deals with a new class […]

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ASBM Executive Director Quoted in FDA News

April 17, 2013

ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King. From FDA Draft Guidance Sets Rules for Biosimilar Meetings: The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars. The document, which provides particulars […]

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Sun Sentinel: Keep doctors informed and patients safe

April 4, 2013

ASBM Advisory Board Member Dr. Bruce Rubin op-ed in the Florida Sun Sentinel: The diagnosis of a chronic, neurological condition like Multiple Sclerosis can be a shock to a patient and his or her family. From my experience as a neurologist, families often have a barrage of questions after receiving this news: Can it be […]

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