The paper examined biosimilar substitution policies across Europe, looking for commonalities which led to successful and sustainable biosimilar markets. The analysis identified six principles the authors refer to as the “Gold Standard”:

• Policies should be designed to incentivize and reward innovation in all types of biologicals.
• Healthcare financing must take into account societal benefits derived from biological medicines, as well as the unique characteristics of biologicals.
• Procurement practices must provide for multiple suppliers and a minimum term of 12 months.
• Physicians must have autonomy to choose the most appropriate medicine for their patient, including making decisions on switching, which must also be consented to by the patient; no automatic substitution.
• Mandatory brand-name prescribing to avoid unintended switches and a robust pharmacovigilance system to report adverse drug reactions (ADRs).
• Policies with potential to undermine sustainability, such as measures which induce biosimilar uptake or promote preferential treatment, thereby limiting physician choice, should be avoided.

The paper also identified three “Must-Haves” for a sustainable biosimilar market:

• Physicians should have the freedom to choose between off-patent originator biologicals and available biosimilars and to act in the best interest of their patients based on scientific evidence and clinical experience.
• Tenders should be designed to include multiple value-based criteria beyond price, e.g. education, services, available dose strengths, and provide a sufficient broad choice (multi-winner tenders versus single-winner tenders) to ensure continuity of supply and healthy competition.
• A level playing field between all participating manufacturers is the best way to foster competition; mandatory discounts which place artificial downward pressure on manufacturers do not engender a sustainable market environment.

Read the whitepaper here. 

FDA Issues Draft Guidance on Biosimilarity and Interchangeability

On November 19th, the US Food and Drug Administration (FDA) issued new Draft Guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
The document offers insights into how FDA will handle certain aspects of submissions and labeling for interchangeable biosimilars.

These include how an applicant may seek FDA review for licensure for an interchangeable biosimilar, and how a 351(a) BLA holder should proceed if it seeks licensure of its biological product under section 351(k) as biosimilar to or interchangeable with another biological product licensed under section 351(a) (a “reference product”). In addition, the document discusses recommendations for labeling of interchangeable biosimilars.

When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
Comments will be accepted on the Draft Guidance until January 19, 2021.

Read the Draft Guidance here.
Comments may be submitted here. 
 

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access hosted its fifth annual National Policy & Virtual Summit on Biologics. As part of the Summit, ASBM Chair Madelaine Feldman, MD, FACR, was interviewed by AfPA’s Gavin Clingham about ASBM’s new whitepaper “US Biosimilars Market on Pace with Europe”; published in GaBI Journal. The paper is co-authored by Dr. Feldman along with ASBM’s Executive Director Michael Reilly.

As Dr. Feldman explains, the paper demonstrates FDA is moving at approximately the same pace as EMA based on the number of approvals at the same time after implementation of its regulatory pathway:

• As of September 2020, approximately 10 years after implementation of the biosimilar approval pathway, 28 biosimilars have been approved by FDA, with 18 of those approvals granted in the last 2 years. For comparison, in the 10-year time period following the creation of Europe’s biosimilar regulatory pathway, EMA approved just 13 biosimilar products (some of which were marketed under several different brands)
• Currently, there are 46 biosimilars approved in Europe; however, these estimates fall to 35 when products approved in the US as follow on biologicals via the 505(b)(2) pathway, e.g. somatropin, insulin, teriparatide, or abbreviated new drug application (ANDA) are excluded. Furthermore, Europe’s filgrastim biosimilar Tevagrastim®/Ratiograstim® was approved as Granix® (tbo-filgrastim) in the US via a Biologic License Application (BLA) prior to the implementation of a biosimilars approval pathway and is not included in the US biosimilar count.

In addition, US biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years:

• As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share.
• Bevacizumab and trastuzumab biosimilars, launched in 2019-2020 have approximately 40% share.
• Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

Watch Dr. Feldman’s interview here.

Read the full whitepaper here. 

View the entire National Policy & Virtual Summit on Biologics here.

On November 15th, ASBM submitted comments on the United Kingdom’s Medicines and Healthcare products Regulatory Agency’s (MHRA’s) guidance intended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

Among the elements addressed in ASBM’s comments was the language surrounding the need for comparative efficacy trials. The MHRA Guidance stated “In most cases, a comparative efficacy trial is not considered necessary.” From ASBM’s comments:
Given that it is not possible to create a structurally identical copy of a reference product, ASBM believes that a comparative clinical study will generally be warranted to rule out the existence of any clinically meaningful differences between the proposed biosimilar and the reference product. While there are cases in which a comparative efficacy trial is not warranted (ie, when structure, physicochemical characteristics, and biologic activity can be well characterized and clinically relevant PD parameters are available), we believe this will be a minority of biosimilar products and recommend the language in the guidelines be amended to state,

“In some cases, a comparative efficacy trial is not considered necessary”.

With regard to biosimilar substitution practices, however, MHRA’s guidance states:

The decision rests with the prescriber in consultation with the patient, who needs to be aware of the brand name of the product received. Substitution at the pharmacy level without consulting the prescriber is not permitted for biological medicines, including biosimilars.
This provision is constent with subsitution practices throughout nearly every European country, and with ASBM’s position. From ASBM’s comments:

Around the world, substitution decisions are largely handled at the local government level; in the US, the decision of whether a biosimilar is substitutable is made at the state level. In Canada, this decision is made at the provincial level, while within the European Union, the decision is made by individual Member States. ASBM believes that patients and their physician should remain in control of their treatment decisions, rather than an insurer, government, pharmacy, or other third party. We support MHRA’s position on the prohibition of automatic substitution.

On November 5th and 6th, ASBM exhibited virtually at American College of Rheumatology (ACR) Convergence 2020. The virtual conference took place ran from November 5 – 9, with dedicated exhibit hours on November 5th and 6th. More than 15,000 attendees from 106 countries attended the meeting.

ASBM’s virtual booth promoted recent ASBM whitepapers and posters, including a poster presented at the June 2020 EULAR E-Congress which drew from ASBM’s 2019 survey of rheumatologists across six Western European countries. Among the issues the survey covered are prescriber attitudes toward prescribing biosimilars to new patients, switching patients to biosimilars, and toward third party-initiated substitutions for nonmedical reasons. Key findings included:

• Rheumatologists were the most with familiar with biosimilars among the practice areas surveyed (99% familiar).
• They had a higher than average comfort level prescribing biosimilars to new patients: 60% of rheumatologists were “very comfortable” doing so, while the average figure across the ten specialties surveyed was 34%.
• Rheumatologists were also the least comfortable with a third party switching their patient for non-medical reasons (e.g. cost): 49% were “very uncomfortable” with this practice, compared to an average of 29% across all specialties.

Read more about ACR Convergence 2020 here. 

View the EULAR 2020 poster here. 

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Saudi Gastroenterology Association Conference

Virtual – December 9, 2020

DIA Latin America Regulatory Conference

Virtual – February 22-23, 2021

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021