Safe Biologics

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.

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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.

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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.

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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.

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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.

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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.

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Orange County Register
By Thair Phillips, President, RetireSafe

The biotech revolution has brought hope to millions of Americans coping with some of the most devastating medical conditions, including cancer, Parkinson’s disease and rheumatoid arthritis. New prescription drugs, known as biologics, that were born of this revolution now comprise the fastest-growing segment of the pharmaceutical market and could account for half of all new drugs approved by 2015.

With intense pressure on governments to control rising health care costs, a push is underway to introduce lower-cost biotech medicines that function more or less as equivalents of these biologics. But a host of complicating factors surrounding biologics – not least of which is patient safety – have doctors, patients, drug companies, and regulators trying to work through the thorny problems unique to these drugs.

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