Biosimilars 101: What are biosimilars and why should you care?
December 1, 2011
Presented by Dr. Richard Dolinar, MD
- What are biosimilars
- Why are biosimilars not generics
- Manufacturing
- The FDA’s “biosimilar pathway”
- Policy Considerations
Biosimilars 101: What are biosimilars and why should you care?
December 1, 2011
Presented by Dr. Richard Dolinar, MD
- What are biosimilars
- Why are biosimilars not generics
- Manufacturing
- The FDA’s “biosimilar pathway”
- Policy Considerations
Biologics 101: What are biologics and why should you care?
November 17, 2011
Presented by Alliance Chairman, Dr. Richard Dolinar, MD
- Role of biotechnology in medical advancements
- What are biologics
- Examples of biologic medicines
- Manufacturing process
- Chemical drugs vs. biologic medicines
- Implications of size, variability, complexity
- What’s next for biotechnology
Alliance for Safe Biologic Medicines Launches Webinar Series
November 12, 2011
Alliance for Safe Biologic Medicines Launches Webinar Series
Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free!
Biologics 101: What are biologics and why should you care?
Thursday, November 17, 2:30 PM EST
Click here to Register!
- Role of biotechnology in medical advancements
- What are biologics
- Examples of biologic medicines
- Manufacturing process
- Chemical drugs vs. biologic medicines
- Implications of size, variability, complexity
- What’s next for biotechnology
Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST
Click here to register!
- What are biosimilars
- Why are biosimilars not generics
- Manufacturing
- The FDA’s “biosimilar pathway”
- Policy Considerations
Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST
Click here to register!
- What is pharmacovigilance
- Track & Trace systems for biologic medicines
- Coding, Naming, Labeling
- Down the Road: Interchangeability and Drug Substitution
Alliance for Safe Biologic Medicines Launches Webinar Series
November 12, 2011
Alliance for Safe Biologic Medicines Launches Webinar Series
Starting in November, The Alliance for Safe Biologic Medicines will host several webinars on biologic and biosimilar medicines, hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free!
Biologics 101: What are biologics and why should you care?
Thursday, November 17, 2:30 PM EST
Click here to Register!
- Role of biotechnology in medical advancements
- What are biologics
- Examples of biologic medicines
- Manufacturing process
- Chemical drugs vs. biologic medicines
- Implications of size, variability, complexity
- What’s next for biotechnology
Biosimilars 101: What are biosimilars and why should you care?
Thursday, December 1, 2:30 PM EST
Click here to register!
- What are biosimilars
- Why are biosimilars not generics
- Manufacturing
- The FDA’s “biosimilar pathway”
- Policy Considerations
Pharmacovigilance 101: What is it and why is it important?
Thursday, December 15, 2:30 PM EST
Click here to register!
- What is pharmacovigilance
- Track & Trace systems for biologic medicines
- Coding, Naming, Labeling
- Down the Road: Interchangeability and Drug Substitution
About the FDA and Biosimilars
November 4, 2011
By Bruce Rubin
MedPage Today
Although politicians and patients may debate the benefits and drawbacks of the U.S. healthcare system, when it comes to inventing new medical technologies and discovering life-saving treatments, no other nation matches the U.S. in terms of innovation and delivery of care.
One reason the U.S. is so successful is that our regulatory system fosters the right balance between the need to ensure patient safety and the desire to produce cost-effective treatments.
Yet, the Food and Drug Administration is currently faced with another issue that will test its ability to find that balance.
The 2010 healthcare reform bill included a provision calling on the FDA to create an expedited pathway for approving biosimilars — the nonidentical “generic” versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis. The FDA may issue guidance on the subject any day now.
FDA’s “Pathway on Biosimilars” Forthcoming
October 6, 2011
The FDA’s Janet Woodcock recently appeared on BioCenturyTV and in a web exclusive she addresses a potential ‘biosimilars pathway’. Though she declined to comment on the specific clinical and nonclinical standards, she made clear that the approval pathway for a biosimilar is different from that of a biologic. She also said that biosimilar interchangeability is “feasible” for certain products.
Watch the two shows here
Alliance’s Dolinar Headlines Boston Biosimilars Event
October 5, 2011
By Kathy Feegal
Dr. Richard Dolinar, the Alliance’s chairman, was a keynote speaker at a biosimilars roundtable discussion in Boston, MA on October 5, 2011. The event was hosted by Northeastern University and was attended by numerous stakeholders from across New England, including the Massachusetts Medical Society, and patients groups such as the National Kidney Foundation; American Cancer Society; AIDS Action; as well as elected officials and policymakers from the state legislature.
Drug costs, benefits must align
October 5, 2011
Dr. David Charles, Chairman, Alliance for Patient Access
The Tennessean
In 1993, a drug just approved by the Food and Drug Administration was highlighted in a Fortune magazine article under the eye-catching headline “Fortune Products of the Year.”
The drug was Betaseron. And while the headline was ambitious, the new drug was a medical triumph. It provided doctors with the first successful treatment for multiple sclerosis, a progressive and disabling neurological disorder that often strikes in the prime of life.
But even more important than Betaseron’s clinical success is its origin. It belongs to an exciting new category of drugs known as “biologics.” These medical breakthroughs are manufactured from living biological processes instead of the more basic chemical processes used to produce conventional pharmaceuticals. Betaseron was one of the world’s first modern-day biologics and it changed the course of medicine forever.
Drug costs, benefits must align
October 5, 2011
Dr. David Charles, Chairman, Alliance for Patient Access
The Tennessean
In 1993, a drug just approved by the Food and Drug Administration was highlighted in a Fortune magazine article under the eye-catching headline “Fortune Products of the Year.”
The drug was Betaseron. And while the headline was ambitious, the new drug was a medical triumph. It provided doctors with the first successful treatment for multiple sclerosis, a progressive and disabling neurological disorder that often strikes in the prime of life.
But even more important than Betaseron’s clinical success is its origin. It belongs to an exciting new category of drugs known as “biologics.” These medical breakthroughs are manufactured from living biological processes instead of the more basic chemical processes used to produce conventional pharmaceuticals. Betaseron was one of the world’s first modern-day biologics and it changed the course of medicine forever.
