Other – Page 12 – Safe Biologics

Dolinar Addresses DIA: Quality, Manufacturing Transparency Key to Avoiding Drug Shortages

July 25, 2013

June 24, 2013 Speaking at the 49th Annual Drug Information Association (DIA) Conference in Boston, Richard Dolinar, M.D., presented an analysis of past drug shortages and discussed how policies toward biologic drugs can be developed to guard against short supply. Dolinar’s presentation, entitled “Characterizing Drug Shortages and Their Causes: Anticipated Future Trends,” stresses that quality […]

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 […]

Indianapolis Business Journal LTE: Biologics misunderstood

April 2, 2013

In “Profits at center of biosimilars debate” [March 18], the author refers to attempted copies of biotech medicines as “generic biotech medicines.” This demonstrates a fundamental misunderstanding of biosimilars. Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to […]

Indianapolis Business Journal LTE: Biologics misunderstood

April 2, 2013

In “Profits at center of biosimilars debate” [March 18], the author refers to attempted copies of biotech medicines as “generic biotech medicines.” This demonstrates a fundamental misunderstanding of biosimilars. Biologics are complex molecules that cannot be copied, whereas generics are exact copies of chemical drugs. Failure to understand this distinction results in a failure to […]

ASBM Advisory Board Member Quoted in Inside Health Policy Article

March 15, 2013

On March 14, ASBM Advisory Board Member, Dr. Harry Gewanter was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up.” The article says: “Harry Gewanter, a pediatric rheumatologist and Alliance for Safe Biologic Medicines board member, rebutted arguments from the sponsor of the Virginia bill, […]

ASBM Advisory Board Member Quoted in Inside Health Policy Article

March 15, 2013

On March 14, ASBM Advisory Board Member, Dr. Harry Gewanter was quoted in the Inside Health Policy Article “North Dakota Projects Lost Savings With Biosimilar Bill; Cost Debate Heats Up.” The article says: “Harry Gewanter, a pediatric rheumatologist and Alliance for Safe Biologic Medicines board member, rebutted arguments from the sponsor of the Virginia bill, […]

Forbes: Blood Drug Woes Could Weigh on FDA and its Approval of New, Copycat Biologic Medicines

February 27, 2013

The announcement last night that Affymax (NASDAQ: AFFY) is recalling all lots of its red blood cell stimulating medicine Omontys could have broader implications for how the Food and Drug Administration (FDA) evaluates similar drugs going forward. Omontys was recalled following some fatal, severe allergic (anaphylactic) reactions that occurred within 30 minutes of receiving the […]

ASBM One Pager on Automatic Substitution

February 19, 2013