January 13, 2015
Amgen Canada has created two new videos explaining the differences between biologics and biosimilars. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.
Watch the videos here.
January 13, 2015
The controversial issue of biosimilar naming is seemingly absent from the FDA drug center’s 2015 guidance agenda as all signs point to the agency approving the first U.S. biosimilar by early March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.
Read the full article here.
January 8, 2015
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FDA Hosts Public Hearing on Biosimilars On January 7, ASBM members Global Colon Cancer Association (GCCA), Global Healthy Living Foundation (GHLF) and the Alliance for Patient Access (AfPA) all testified at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public hearing on biosimilars. The patient groups expressed support for the pending approval, but also outlined what was needed to continue to grow patients’ confidence in the biosimilars program. In his testimony, Andrew Spiegel, GCCA executive director and ASBM Steering Committee member, said: “Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.” Read his full testimony here. ASBM Quoted in FDA Week on Biosimilars Meeting ASBM Executive Director Michael Reilly was interviewed by FDA Week prior to the ODAC meeting on how the meeting was an important opportunity for the FDA to hear from stakeholders. From Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate: “The advisory hearing could serve as an important platform for FDA to hear stakeholders’ input on issues such as biosimilar naming as the agency nears its possible first biosimilar approval, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines. The first approval will reveal the agency’s thinking on biosimilar naming as well as other issues surrounding the data and tests required as part of the review process, he added.” Read more here. |
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FDA Releases List of Upcoming Biosimilar Guidances for 2015 On January 6, the FDA released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity. Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars and how interchangeability will be determined. Read more here. |
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Physician Groups Advocate for Unique Names The Alliance for Patient Access and other specialty physician groups wrote a letter to the FDA on the importance of giving biosimilars unique names. On December 26, FDA Week highlighted their position in Some Doctors Push Distinct Biosimilar Names, Breaking from AMA Stance: “A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution. “The specialty physician groups wrote to FDA Thursday (Dec. 18) that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to ‘imply pharmacologic interchangeability of products with the same active ingredient(s).’“ Read more here. |
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New ASBM Canadian Survey Released at Ottawa Workshop On December 10, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey of physicians’ views at the Subsequent Entry Biologics in Canada: Current State of the Science workshop in Ottawa. The goal of the Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly for naming. The survey included 427 prescribers made up of dermatologists, gastroenterologists, internists, oncologists, pulmonologists, neurologists, urologists, nephrologists, rheumatologists and endocrinologists. The physicians were from four provinces in Canada – Alberta, British Columbia, Ontario and Quebec. Read more here. |
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ASBM to Offer Class on Biosimilars to Pharmacists ASBM is organizing a CE class for pharmacists on the fundamentals of biologics that will be offered through the Long Island School of Pharmacy. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will help pharmacists: 1. Discuss the basic science and manufacturing of biologic medicines. The class will be held on March 15 at the New York LaGuardia Airport Marriott. |
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Upcoming Conferences:
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January 8, 2015
A government panel Wednesday took a major step toward approving a copycat version of a blockbuster cancer drug, paving the way for a new class of cheaper medicines that could save consumers billions of dollars.
An expert Food and Drug Administration panel unanimously recommended that the government approve the drug known as EP2006, a lower-cost imitator of a popular medicine called Neupogen, used to help cancer patients fight off infection while undergoing chemotherapy. The FDA usually accepts recommendations from advisory panels but is not required to.
Read the article here.
January 7, 2015
On January 7, Andrew Spiegel, executive director of the Global Colon Cancer Association and ASBM Steering Committee member, presented before the U.S. Food and Drug Administration (FDA) providing a patient perspective on why safety must be the ultimate priority when approving biosimilars.
During his oral presentation before at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public meeting he said the following:
“Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.
“Another key to effective pharmacovigilance would be for the FDA to require any approved biosimilar to have a nonproprietary name distinguishable both from its reference biologic, as well as from other approved biosimilars. This will allow for physicians, pharmacists to know exactly which medicine their patient is receiving, ensure accurate attribution and tracking of adverse events, hold manufacturers accountable for the safety of their products, and help all of us better understand how these medicines work. ”
View his full testimony here.
January 6, 2015
On December 24, FDA Week quoted ASBM Executive Director, Michael Reilly, on how the upcoming January 7th FDA Meeting on Biosimilars will be an important opportunity for the FDA to hear from stakeholders.
Read the full article Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate here.
January 6, 2015
On January 6, the U.S. Food and Drug Administration (FDA) released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity.
Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars and how interchangeability will be determined.
The titles of the forthcoming biosimilarity guidances will be as follows:
The full 2015 CDER Guidance Agenda may be read here.
January 3, 2015
From FDA Week:
A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution.
Read the full article here.
December 11, 2014
On December 10th, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey at the Subsequent Entry Biologics in Canada: Current State of the Science workshop presented by the Canadian Society for Pharmaceutical Sciences and cohosted by BIOTECanada in Ottawa. The Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey, is a new survey of Canadian physicians’ views of biosimilars. The goal of the survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly in regard to naming. Physicians were asked about their familiarity and understanding of SEBs, the implications of an SEB sharing a non-proprietary name with its reference innovator product, how they identify biologics in patient records and in adverse event reporting, their perspective on the importance of distinguishable naming and their attitudes on pharmacy substitution.
View the presentation here.
December 8, 2014
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Survey Presentation at Spanish Ministry of Health On November 25, Executive Director Michael Reilly presented the European Survey results at the “1st EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality in Madrid. The event was hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO) and was the first time specific Spanish responses and data were presented and compared to responses from physicians in the other countries surveyed. Mr. Reilly pointed out that while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars and almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before. Additionally, physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker. The meeting included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups. Read the press release here. |
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DIA Biosimilars Conference in Berlin On December 2, ASBM Executive Director Michael Reilly presented results from the European Survey at the DIA Biosimilars Conference held in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars. ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. Read more here. |
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Dr. Gewanter Responds to Hill Op-Ed On November 18, Dr. Gewanter responded to an Op-Ed in The Hill by Tom Schatz, president of Citizens Against Government Waste, by pointing out that biosimilars were wrongly categorized in his piece as a trade/competition issue when it is really a patient safety issue. Dr. Gewanter wrote the following statement: “But Mr. Schatz makes a common error in equating biologic medicines with chemical medicines. Unlike generic copies of chemical medicines, the complexity of biologics means that an attempted copy will never be identical. A biologic produced from a different cell line can, at most, be ‘similar,’ hence the term ‘biosimilars.’ This scientific reality is why biologics cannot simply be treated as generics by regulators. Even minor differences can create adverse impact in patients, including unwanted immune responses. How similar is ‘similar enough’ to safeguard patient safety? The Food and Drug Administration (FDA) has wisely taken its time in drafting approval criteria and other guidance to answer that question accurately.” Read more here. |
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Rep. Bobby Rush Op-Ed in Huffington Post On November 6, Rep. Bobby Rush (D-Ill.) penned an Op-Ed for the Huffington Post on his concerns for ensuring safety as biosimilars are approved in the U.S. In Biosimilars – Another Untold Story of the Affordable Care Act he says: There is “an earnest debate, currently taking place both in Washington, DC and in state capitals across the country, about how laws governing pharmacy practices can be updated to expand access to these drugs. While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars. “Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient’s medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.” Read more here. |
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GaBI Newsletter Features ASBM WHO Presentation On November 11, ASBM was highlighted in the Generics and Biosimilars Initiative (GaBI) newsletter for presenting on naming at the WHO 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. From More Discussion on WHO Biological Qualifier: “During the meeting, which took place from 14–16 October 2014, the Alliance for Safe Biologic Medicines (ASBM) gave a presentation on ‘Global biosimilar naming standards: physician (and patient) perspectives’ in support of the WHO’s draft biological qualifier (BQ) proposal. “The WHO BQ proposal would assign a four-letter alphabetic code to all biologicals [1]. The ASBM, which represents healthcare, patient and physician groups, as well as originator biologicals companies, believes that the WHO’s BQ will prioritize patient safety. In September 2014, the ASBM and 14 of its member groups submitted comments to WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.” Read the article here. |
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Medscape Interview with Dr. Margaret Hamburg Eric Topol, Editor-in-Chief of Medscape, sat down with Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), as part of the Medscape series on the most interesting people in medicine. In the interview “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” Dr. Hamburg addresses biosimilars. Watch the interview here. |
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EMA Revises Biosimilars Guideline In October, the European Medicines Agency (EMA) published a revised version of its 2005 overarching biosimilars guidelines that contains new recommendations on how to bring biosimilars to market in Europe. Read more here. |
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