FDA says trust and education critical for biosimilars

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The US Food and Drug Administration (FDA) has highlighted trust and education as critical factors in ensuring patient access to biosimilars.

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In a keynote address at the Generic Pharmaceutical Association’s (GPhA) annual Biosimilars Council Conference, Dr Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) emphasized the importance of education and the need for patients, providers, pharmacists and others to trust in the science that enables FDA to approve biosimilars as safe, effective alternatives to costly brand-name biologicals.

The 2016 GPhA Biosimilars Council Conference: Leading on Biosimilars was held in North Bethesda, USA on 7−8 September 2016 and included presentations from key industry leaders, agency officials and academic experts on areas of focus including education, access, regulatory environment, reimbursement and legal affairs.

Dr Bert Liang, Chairman of the Biosimilars Council and Chief Executive Officer at Pfenex agreed with Dr Woodcock, saying that ‘patients, physicians and pharmacists can be assured that FDA approved biosimilars are just as safe and effective as their brand-name biological counterparts’. He added that the success of biosimilars ‘will rely on educating and earning the trust of patients and providers’.

In her speech, Dr Woodcock also acknowledged that FDA will need to expand its capacity in order to address the increasing number of biosimilars applications. The Biosimilars Council, while recognizing that FDA approved biosimilars are medicines that can be trusted, is concerned that ‘efforts to undermine this trust by misrepresenting sound scientific principles, such as bioequivalence standards, are worrisome and widespread’. They believe that ‘misinformation can be countered with improved understanding of proven science – but it will take a collaborative effort between stakeholders from all points of the supply chain’.

Dr Liang concluded that ‘confidence in these scientific principles should carry through to policy conversations. Decisions made today are forming the foundation responsible for patient access to these medicines. Building confidence in biosimilar safety and efficacy will help millions of Americans realize the promise of biosimilars – expanded access to more affordable medicine and billions of dollars in patient and health system savings’.

Lack of awareness and education about biosimilars has previously been highlighted as a barrier to prescribing among American doctors [1]. Although private initiatives, such as that of the Biosimilars Forum (Partnership for Biosimilars Education and Access) have been launched [2], there is yet to be a major push from the US Government or FDA to raise awareness and educate both patients and prescribers.

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1. GaBI Online - Generics and Biosimilars Initiative. Doctors’ survey reveals lack of confidence in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Reports/Doctors-survey-reveals-lack-of-confidence-in-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Launch of partnership for biosimilars education and access [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 21]. Available from: www.gabionline.net/Biosimilars/General/Launch-of-partnership-for-biosimilars-education-and-access

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Source: GPhA

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