Safe Biologics

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.

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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.

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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.

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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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