Safe Biologics

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

FierceBiotech
By John Carroll

Will FDA officials raise the regulatory bar on biosimilars so high they can’t be competitive in the U.S.?  Longtime researcher and Parexel consultant Dr. Saurabh Aggarwal seems to think there’s a very high risk of that.

In an interview with Scientific American blogger Khadijah Britton, Aggarwal says that the FDA’s latest stab at outlining the approval process for biosimilars highlights just how complex and expensive this will be. Add in an even tougher approval process that will be needed to achieve interchangeability-the right for pharmacists to substitute a branded biologic with a biosimilar–along with increasing signs that payers and providers won’t settle for anything less, he adds, and you have a recipe for failure.

Read More

PharmaTimes
By Lynne Taylor

To feel comfortable with generic biologics (biosimilars), US payers are likely to require more clinical information than what might be accepted by the Food and Drug Administration (FDA) for approvals, a new report suggests.

For example, FDA approval of biosimilar versions of monoclonal antibodies (MAbs) for oncology indications will not allay all the concerns felt by the majority of payers about bioequivalence, says the report, from research firm Decision Resources.

Read More

PharmaTimes
By Lynne Taylor

To feel comfortable with generic biologics (biosimilars), US payers are likely to require more clinical information than what might be accepted by the Food and Drug Administration (FDA) for approvals, a new report suggests.

For example, FDA approval of biosimilar versions of monoclonal antibodies (MAbs) for oncology indications will not allay all the concerns felt by the majority of payers about bioequivalence, says the report, from research firm Decision Resources.

Read More

Reuters
By Anna Yukhananov

Evaluating generic versions of complex biotechnology medicines will require a new, more rigorous review process, U.S. drug regulators said, in the first glimpse of their thinking on the subject.

Drugmakers, investors and others have been clamoring for more insight into the approval process for cheaper versions of biotech drugs, known as “biosimilars” — a potentially multibillion dollar market.

In an article in this week’s New England Journal of Medicine made public on Wednesday, officials from the U.S. Food and Drug Administration said the approval for biosimilars “will require a new paradigm of sponsor-FDA interactions,” involving analysis of much more data than traditional generics.

Read More

By Helena R. Berger, Executive Vice President & CEO, American Association of People with Disabilities
Buffalo News

The future of medicine is biologic drugs. Not only have they revolutionized the medical treatments of serious diseases, they have also transformed treatments for many people with disabilities – from offering new promise to people with multiple sclerosis to aiding those with debilitating arthritis.

A lot has been written about how the Food and Drug Administration may soon approve biosimilars, the first attempted copies of biologics. But as part of an ongoing commitment to support efforts to assure accessible, high-quality and affordable health care for people with disabilities, we must ensure that patient safety is at the forefront of public policy discussions as they relate to their approval and usage.

Read More.

By Helena R. Berger, Executive Vice President & CEO, American Association of People with Disabilities
Buffalo News

The future of medicine is biologic drugs. Not only have they revolutionized the medical treatments of serious diseases, they have also transformed treatments for many people with disabilities – from offering new promise to people with multiple sclerosis to aiding those with debilitating arthritis.

A lot has been written about how the Food and Drug Administration may soon approve biosimilars, the first attempted copies of biologics. But as part of an ongoing commitment to support efforts to assure accessible, high-quality and affordable health care for people with disabilities, we must ensure that patient safety is at the forefront of public policy discussions as they relate to their approval and usage.

Read More.