Safe Biologics

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 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 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. 

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.

Read the WHO’s summary of the 73rd INN Consultation here.

View ASBM’s presentation from the 73rd INN Consultation 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.

Read the WHO’s summary of the 73rd INN Consultation here.

View ASBM’s presentation from the 73rd INN Consultation here. 

From March 9-11, ASBM participated in the Festival of Biologics USA 2022, held in San Diego, California. Several ASBM representatives presented on a variety of topics, and participated in several discussion panels at the three-day conference.

On March 9th, ASBM Advisory Board Chair Philip Schneider gave a plenary presentation on the current biosimilars landscape, highlighting factors which are contributing to biosimilars gaining market share in the U.S. Among these are greater discounts resulting from increased competition, as well as greater physician confidence in biosimilars due to strong FDA data requirements and increased familiarity. View his presentation here. 

On March 11th, Schneider gave a presentation in the conference’s “Real World Evidence” (RWE) track entitled “Problems with pharmacovigilance programs: Opportunities for improvement.” This presentation highlighted some of the unique pharmacovigilance challenges of biosimilars, areas of concern, and strategies for improving biosimilar pharmacovigilance globally.  View this presentation here: Part 1 Part 2

Following his presentation, Schneider moderated one of the conference’s two closing panel discussions, entitled “Promoting biosimilar uptake”. This discussion examined the impact of interchangeable biosimilars on the biosimilar landscape and the role of competition in an increasingly active biosimilars pipeline.

The second closing panel discussion was moderated by ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. It is entitled “Market access dynamics and the future across different therapeutic areas” and will examine (e.g. arthritis, oncology, ophthalmology, hematology, etc).

One topic of this discussion was the possibility of switching patients at the Veterans Health Administration (VHA) en masse to preferred biosimilars, in order to realize cost savings across a large health system. Mr. Spiegel raised concerns with this approach, citing a recent study published in the journal Current Medical Research and Opinion, which examined US VHA patients who were switched from innovator infliximab to the VHA-preferred biosimilar. The study found that those who were switched from the reference product to the biosimilar were almost 3 times more likely to stop treatment and 5 times more likely to switch to another innovator biologic.

The study also found that 91% of the patients who stopped the biosimilar switched back to the originator product. “Reasons for discontinuation and switching are unknown,” investigators wrote in the study.

Learn more about the Festival of Biologics USA 2022 here. 

On March 9th, a bill was introduced in the U.S. House of Representatives that would eliminate the requirement for a biosimilar to have the same strength as the originator product upon which it is based.

H.R. 7047, the “Lowering Costs by Improving Biosimilar Uptake Act”, would amend title III of the Public Health Service, permitting the Secretary of Health and Human Services to waive this approval requirements:

(I) The Secretary may determine, in the Secretary’s discretion, that an element described in clause (i)(I), or in clause (i)(IV) with respect to the strength of a biological product, is unnecessary in an application submitted under this subsection.

In addition to having the same benefits, potential side effects, and route of administration and the originator product- biosimilars are currently required to have the same dosage and strength as the reference product.

The bill has been referred to the U.S. House Energy and Commerce Committee. ASBM will continue to monitor its progress.