Safe Biologics

On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq.

Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and co-authored by Reilly and Schneider.

The paper examined biosimilar substitution policies across Europe, identifying factors which led to their 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. 

On December 9th, ASBM Advisory Board Chair Philip Schneider presented virtually to the Saudi Society for Rheumatology. The presentation was carried live to gatherings of rheumatologists in Riyadh, Saudi Arabia; Kuwait City, Kuwait; and Baghdad, Iraq.

Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and co-authored by Reilly and Schneider.

The paper examined biosimilar substitution policies across Europe, identifying factors which led to their 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. 

On November 22nd and 29th, ASBM Executive Director Michael Reilly and Advisory Board Chair Philip Schneider presented to the Saudi Gastroenterology Association. The 45-minute presentation was livestreamed to gatherings of several hundred gastroenterologists in the three largest cities in Saudi Arabia: Riyadh, Jeddah, and Dammam. Entitled “Lessons from European Biosimilar Markets”, the presentation was based on the whitepaper “Policy recommendations for a sustainable biosimilars market: lessons from Europe” published February 2020 in the GaBI Journal and coauthored by Reilly and Schneider.

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.

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 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. 

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.