April 18, 2012
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.
April 17, 2012
by RICHARD DOLINAR, MD
As a treating physician who also serves as the Chairman of the Alliance for Safe Biologic Medicines (ASBM), I have been watching with great interest as the Food and Drug Administration (FDA) begins to unveil the approach it will take to bring “biosimilar” medications to the US. Biosimilars are attempts to replicate brand name biologic medicines. But as the name indicates, they are similar to them but not identical. Interestingly, when you look up the definition for “identical” in the dictionary it reminds us that it means to “have such a near similarity or resemblance as to be essentially equal or interchangeable.”
April 16, 2012
Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products
Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps to ensure that patient safety is at the forefront of the biosimilars pathway.
While the FDA’s proposed framework demonstrates the agency’s thoughtful approach, ASBM stated in its comments that effective implementation of the biosimilars pathway must incorporate prudent measures, including:
Within its comment letter, the Alliance for Safe Biologic Medicines outlines clear, concrete, and achievable ways to manage risk and thereby prioritize patient safety.
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines released the following statement as he submitted the coalition’s comments to the docket:
We are pleased with the FDA biosimilar draft guidance but it leaves a lot of questions unanswered — particularly when it comes to the requirement of clinical studies and pharmacovigilance.
There can be no grey area when it comes to patient safety. Unwanted immunogenicity is the preeminent safety challenge associated with biological therapeutics and can result in unexpected or sometimes severe adverse effects.
The predictive value of animal studies is often insufficient to characterize immunogenicity in humans. Clinical studies, in addition to analytical methods, are necessary to weed out ineffective and unsafe drugs — innovator biologics and biosimilars — before they are ever a risk to patients.
In the unfortunate situation that problems arise, measures must be in place to accurately and promptly connect a specific patient to a specific product. Our current pharmacovigilance system is not equipped to distinguish a biologic reference product from its biosimilars. Unique nonproprietary names for biosimilar and innovator compounds ensure we will be able to effectively track and trace a product to an adverse event. This must be implemented prior to biosimilar market entry.
The Alliance for Safe Biologic Medicines will continue to work with the FDA to outline an approval pathway that enables physicians to confidently prescribe biosimilar medicines.
On February 9, the FDA released draft guidance on the biosimilars approval pathway and requested written comments by April 16.
To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.
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About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at www.safebiologics.org
April 11, 2012
By Dr. Richard Dolinar
Chairman of the Alliance for Safe Biologic Medicines
(Published April 5, 2012)
Excerpt:
Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused on safety, they failed to provide clarity around what measuring stick the FDA will use to determine if a product is similar. We know that clinical trials could be used to prove that they are trustworthy.
But we need to find the questions that must be answered by manufacturers of biosimilars to make doctors rest easy when prescribing them. Ultimately, we want to have the same confidence in biosimilars that we have in biologics, but that can only happen if the FDA is clear and specific about the standards to which it is holding biosimilar manufacturers and if the data is available to the public.
March 6, 2012
Chairman Dr. Dolinar Speaks at Top Biosimilars Industry Conference
Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, presented at the CBI’s 7th Summit on Biosimilars and follow-on Biologics on “Track and Trace – The Need for Pharmacovigilance with Biologics”.
The Washington, D.C. event was attended by biologic and biosimilar manufacturers and others in the scientific community. It followed on the heels of the U.S. Food and Drug Administration’s recently released draft guidance on biosimilar medicines, which outlines the steps for biosimilar manufacturers to market their products in the United States. The Agency has yet to outline naming policies for biosimilars.
In his presentation, Dr. Dolinar addressed why track and trace is important in the context of biosimilars and concrete steps to improve patient safety:
“As a practicing physician who has primary responsibility for the health and welfare of my patients, I believe that unique names are a fundamental safety issue. Biologics and biosimilars are unlike chemical drugs as they are made from living cells and any change in environment, raw materials, or manufacturing process can alter the final medicine. Unique names facilitate effective tracking and tracing and actually enable physicians to leverage both their knowledge and experience with products to make treatment choices that are appropriate for a particular patient. Such a track and trace system would also help minimize risk to patients through accurate product attribution of any adverse events.
“It would only take one catastrophe to end the U.S. biosimilar program. That’s why effective implementation of the biosimilars pathway is dependent upon a strong track and trace system that puts patients first and on the knowledge of those on the frontlines of healthcare – the doctor and patient.”
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About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.
March 2, 2012
Dr. Richard Dolinar, a Glendale, Ariz.-based physician who is ASBM’s chairman, noted that chemical medicines are small molecules that treat the symptoms of illness or disease, but that some biologics, which he described as “huge, engineered structures,” can get to the pathways of illnesses like arthritis or cancer.
“A biologic product is not a matter of chemistry but is actually farming with molecular structures,” Dolinar said. “We grow these products at the molecular level, and they are very sensitive to their surroundings. They must be closely monitored during the manufacturing process. If they are changed slightly, there is a chance it will trigger the body immune system and blunt the drug’s effect.”
One reason biosimilars cannot be similar to one another let alone to the referenced product is that the manufacturers will be using different cell lines. “They can make them similar, but not identical,” Dolinar said. Stating that patient safety is of paramount importance, Dolinar stressed the need for pharmacovigilance, which is the detection, assessment, understanding, and prevention of adverse effects – particularly long-term and short-term side effects – of medicines. He indicated that:
Dr. David Charles, a neurologist who was representing the Alliance for Patient Access, agreed with Dolinar that distinct names for biosimilars are necessary. “The whole manufacturing process for biosimilars is so complex that if a patient gets a bad reaction from a drug, we have to be able to find out what was taken,” Charles said. “If we don’t know, then a whole batch of drugs would have to be considered as potentially bad, when it might be that just one company had a manufacturing problem with its biosimilar product.”
February 27, 2012
By Richard Dolinar
A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex medicines known as biologics. These advanced medicines treat serious medical conditions including cancer, multiple sclerosis, and rheumatoid arthritis. Last week, the FDA provided draft guidance that will eventually lead to the introduction of biosimilars in the U.S.
To date, there are no biosimilars in the U.S. market because they were considered “too complex” to include in the 1984 Hatch-Waxman legislation, which regulates the generic drug industry in America. In recent years the European Union, Canada and several other jurisdictions have made biosimilar versions of biologic products available for sale, and the United States is currently following suit.
February 27, 2012
By Richard Dolinar
A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex medicines known as biologics. These advanced medicines treat serious medical conditions including cancer, multiple sclerosis, and rheumatoid arthritis. Last week, the FDA provided draft guidance that will eventually lead to the introduction of biosimilars in the U.S.
To date, there are no biosimilars in the U.S. market because they were considered “too complex” to include in the 1984 Hatch-Waxman legislation, which regulates the generic drug industry in America. In recent years the European Union, Canada and several other jurisdictions have made biosimilar versions of biologic products available for sale, and the United States is currently following suit.
February 27, 2012
Capitol Hill Biosimilars Policy Forum Discusses Recent FDA Guidances
Washington, D.C. – The Alliance for Safe Biologic Medicines (ASBM), a national not-for-profit organization dedicated to ensuring patient safety and access to biologic medicines, partnered with Bloomberg Government to host “Biosimilars Policy Forum: Keeping Patients Safe” on February 27, 2012.
The event followed the release of the U.S. Food and Drug Administration’s long-awaited draft guidances on the approval of biosimilar medicines in the United States. Biosimilars are the imitative versions of existing biologic therapies whose patents have expired.
Panelists commented on the challenges and opportunities associated with the proposed guidelines and the science of these advanced medicines.
The panel was composed of the following speakers:
Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator)
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines
Dr. David Charles, Chief Medical Officer, Vanderbilt Neuroscience Institute, Chairman of the Alliance for Patient Access, and ASBM member partner
Seth Ginsberg, Co-Founder and President of the Global Health Living Foundation, and ASBM member partner
Andrew Spiegel, CEO and co-founder of the Colon Cancer Alliance, and ASBM member partner
Martha Raymond, Patient Support Advocate, Colon Cancer Alliance
Jeffrey P. Kushan, Partner, Sidley-Austin LLP
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines, emphasized that patient safety must continue to preeminently guide regulatory decisions:
“Biologics are sophisticated medicines made from living cells and have highly intricate structures that are not easily understood, characterized or replicated.
The FDA must therefore approach the approval and designation of ‘interchangeability’ of a biosimilar on a case-by-case basis as a biosimilar is similar, but never identical, to innovator biologic.
Moreover, due to the organic nature of these medicines, a biologic and its biosimilar may change over time, diminishing the likeness of both products. This potential outcome – known as ‘product drift’ – must be considered.
To this end, patients and physicians should have the ability to carefully decide the best course of treatment. There should be no automatic substitution between an “interchangeable” biosimilar and its reference biologic without physician consent, or immediate notification at the time of the product substitution.
Lastly, unique names, clear product labels and other robust traceability measures must be implemented.
We appreciate the FDA’s important role in introducing biosimilars in the U.S. As the guidances are finalized, the Alliance will continue to serve as a resource for physicians, patients, lawmakers and regulators.”
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About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.
February 23, 2012
Presented by Dr. Richard Dolinar, MD
