Safe Biologics

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

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

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

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.

Read more

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.

Read more

By Kara Nett Hinckley, Public Policy Coordinator, Colorado Chronic Care Collaborative
Denver Post

How many of us have watched a loved one or friend suffer from a serious illness and wished for a miracle treatment that could help them with their struggle? Biologic drugs are not miracles, but they are a new, often better way of treating many life threatening conditions and chronic diseases. As the Food and Drug Administration outlines the regulatory pathway to replicate biologics – a process that is distinct from creating generic pharmaceuticals – we must ensure proper measures are in place to uphold their safety and effectiveness.

Chronic disease is one of the most challenging and costly healthcare issues in America. In Colorado, one in four – some 1.2 million citizens – live with a chronic disease like diabetes or Multiple Sclerosis​.

The 2010 Affordable Care Act instructed the FDA to outline an approval process for replicated biologics, called biosimilars, following Europe who has worked on a similar framework since 2004.

Read More

By Andrew Spiegel, CEO, Colon Cancer Alliance
The Patriot-News

The lead article in this month’s New England Journal of Medicine was a perspective piece written by key Food and Drug Administration officials on the development of America’s biosimilars program. Biosimilars are the imitative versions of biologic medicines, the miracle drugs to treat serious conditions such as cancer, multiple sclerosis and early Alzheimer’s disease.

As a founder and current CEO of the Colon Cancer Alliance, a patient advocacy group dedicated to helping colon cancer patients, I read the NEJM article intently. I know firsthand that a lot is at stake – for patients, medical practitioners, state legislators and innovation. I have personally witnessed cancer’s devastating effects and felt the hope associated with the development of new, innovative medicines.

Read More