Biologics and Biosimilars: What Patients, Physicians and Advocates Need to Know Access, Patient Safety and Emerging Policy Issues

September 28, 2011

The Alliance for Safe Biologic Medicines joined with the Virginia Biotechnology Association at an event to expore with patients, advocates, physicians and other healthcare providers the importance of maintaining patient safety as the U.S. FDA’s top priority while it works to establish a pathway for approval for biosimilar products. Continue reading…


New medicines bring hope, safety concerns

September 10, 2011

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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Patient safety is essential for new cancer meds

August 25, 2011

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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Patient safety is essential for new cancer meds

August 25, 2011

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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Biosimilars Policy Forum

August 17, 2011

The Alliance for Safe Biologic Medicines and Pennsylvania Bio hosted an event entitled, “Biosimilars Policy Forum: Ensuring Patient Safety” in Philadelphia, PA, on August 17, 2011

The purpose of the forum discussion was to explore with community members, including policymakers, patients, physicians, pharmacists, and hospital officials the importance of maintaining patient safety as the U.S. Food and Drug Administration’s top priority while it works to establish an approval pathway for biosimilar products.
Continue reading…


Is the FDA writing a recipe for the failure of biosimilars in the U.S.?

August 8, 2011

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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Biosimilars: US payers “will want more data than FDA”

August 5, 2011

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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Biosimilars: US payers “will want more data than FDA”

August 5, 2011

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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Developing the Nation’s Biosimilars Program

August 4, 2011

Developing the Nation’s Biosimilars Program
Steven Kozlowski, M.D., Janet Woodcock, M.D., Karen Midthun, M.D., and Rachel Behrman Sherman, M.D., M.P.H.
New England Journal of Medicine
August 4, 2011

Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious clinical conditions. Therapeutic biologics such as genetically engineered recombinant proteins and monoclonal antibodies represent a large portion of newly approved therapies for conditions such as chronic inflammatory diseases and cancer. Biologic enzyme-replacement therapies provide clinical benefits in previously untreatable genetic disorders.

Read the full report here.

 

 


FDA gives glimpse of biosimilar approval process

August 3, 2011

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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