Safe Biologics

On April 29th, ASBM submitted comments to Health Canada as part of a stakeholder consultation on its draft Handbook for healthcare professionals on biosimilar biologic drugs. ASBM’s comments focused on the Handbook’s mixed messaging surrounding biosimilar equivalence and switching, including language which implies inaccurately that Canada’s policies are consistent with those of regulators in US and Europe. From the comments:

In fact, many of the automatic- and forced-substitution policies increasingly being implemented in Canada stand in stark contrast to the substitution practices in Europe and the United States.

In nearly every European county, for example, automatic substitution of biologic medicines at the pharmacy level is banned. Forced substitution is also extremely rare, and in nearly every country, physicians are free to choose between multiple reimbursed products. …An ASBM survey of 403 Canadian physicians, all of whom prescribe biologics, revealed that 64% are not comfortable with a third-party switching a patient to a biosimilar for non-medical (i.e. cost) reasons.

In the United States, automatic substitution is permitted only for biosimilars which have provided additional data to FDA demonstrating no loss of efficacy or additional risks following repeated switching between the biosimilar and reference product…82% of the 403 Canadian physicians surveyed believe such studies should be conducted that measure the effects of switching on patient safety and product efficacy, prior to automatic substitution being permitted.

We suggest softening or clarifying language in the Handbook that implies interchangeability of reference products, emphasizing the importance of prescriber responsibility for determining the choice of a biologic for their particular patient, and acknowledging more accurately the regulations in other countries, particularly the EU and USA.

ASBM’ s comments also touch on pharmacovigilance concerns related to Canada’s lack of distinct non-proprietary names for biologic medicines:

The handbook text correctly and appropriately emphasizes the importance of pharmacovigilance programs and clear product identification when dealing with multiple similar biologic products all sharing a non-proprietary name…[yet] the Canadian physician survey revealed that brand name is not consistently used in reporting and the DIN number is not widely used by clinicians:

• Prescribers record only the non-proprietary name 20% of the time when prescribing, which lead to incomplete patient records and the potential for inadvertent or inappropriate substitution.
• In adverse event reporting, 26% of physicians record only the non-proprietary name.

We suggest Health Canada make reference to the importance of distinguishable non-proprietary names and the current problems of relying solely on brand names and the DIN for documentation in medical records and adverse drug event reports.

Read ASBM’s comment letter here in full. 

On April 14, 2022, the Honourable Jean-Yves Duclos, Canadian Minister of Health, issued a statement announcing the Government’s intention related to the coming-into-force of the Amendments to the Patented Medicine Prices Review Board (PMPRB) Regulations. The Minister’s statement advised that Health Canada will proceed with changing the new basket of comparator countries and will not proceed with any of the other amendments. This is what patient groups have been advocating for since 2018, as the Gastrointestinal Society reports.

On June 20th, ASBM Chairman Ralph McKibbin, MD will present a poster entitled “Physician Perspectives on Biosimilar Substitution and Reimbursement Practices” at the 2022 DIA Global Annual Meeting in Chicago, IL. The poster is based on the findings of ASBM’s September 2021 survey of 401 U.S. physicians. While topline findings have been shared privately in meetings with regulators, the full survey data has not yet been released.

Survey respondents were drawn from twelve specialties in which biologics are routinely prescribed (e.g. dermatology, gastroenterology, nephrology, neurology, oncology, rheumatology, etc.) All respondents prescribe biologics in their practice. Topics examined include:

• Confidence in the safety and efficacy of biosimilars
• Willingness to prescribe biosimilars to a new patient
• Comfort level with physician-instituted non-medical switching
• Comfort level with third-party-initiated non-medical switching
• Implications of an FDA designation of “interchangeable”
• Importance of treatment decision authority
• Importance of payer reimbursement of multiple products in a class
• Importance of reimbursement coverage decisions including factors other than price
• Perspectives on different biosimilar substitution and access scenarios
• Implications of FDA biologic naming conventions

Dr. McKibbin will present the survey findings on June 20th between 12:00-1:15pm at the professional poster exhibit area at the McCormick Center West Convention Hall. The meeting runs from June 19th through the 23rd.

Register for the 2022 DIA Global Annual Meeting here. 

On April 5th, ASBM participated in the World Health Organization’s 74th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the eighteenth INN Consultation in which ASBM has participated. ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.

The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months.

On April 13th, the U.S. Food and Drug Administration (FDA) and The University of Maryland Center of Excellence in Regulatory Science (M-CERSI) held an educational webinar entitled “Biosimilars: A Decade of Experience and Future Directions-Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology”.

In the workshop, leading academic clinicians with specialties in oncology, rheumatology, gastroenterology, and endocrinology shared their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology.

The slides and videos for the workshop are now available for viewing online here. 

On April 7th, ASBM sent a letter to Minnesota lawmakers opposing a bill which could potentially increase costs for patients who receive biologic medicines. The bill, HF 1516, was introduced last session but not ultimately adopted. ASBM led a coalition of patient organizations that raised concerns with the bill last spring. From the letter:

It is our view that HF 1516/SF 990, while intended to promote competition and lower prices, may result in unintended negative consequences- such as actually increasing, rather than lowering, drug costs for Minnesota patients…

In effect, this bill requires a pharmacy benefit manager or health carrier that covers ANY biologic product in a given class, to reimburse ALL products in that class, regardless of its actual cost to the payer. The availability of biosimilars currently places downward pressure on net prices by forcing reference product manufacturers to discount their products heavily in order to compete. By requiring health plans to cover all approved products in a class (regardless of net cost), it effectively creates an incentive for all manufacturers to raise their prices.

While we strongly support legislation that is written with the goal of realizing cost savings through competition between multiple biologic products, we believe that HF 1516/SF 990 undermines this objective by removing current incentives to compete on price and will ultimately reduce rather than promote affordability of biologics.

Read ASBM’s full letter on HF 1516 here. 

ASBM/GCCA Biosimilars Training Program (ON-DEMAND)

LearnBiosimilars.org – May 12, 2022 – May 12, 2023

BIO International Convention

San Diego, CA – June 13-16, 2022

DIA Global Annual Meeting 2022

Chicago, Illinois – June 19-23, 2022