In April and May, ASBM and the Generics and Biosimilars Initiative (GaBI) will host two new webinars examining the implications of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on the unintended consequences that may result from the implementation of IRA provisions. For example, provisions intended to reduce the expenses of biologic medicines in the short term may result in fewer medicines being introduced in the long term, reducing rather than increasing patient access to innovative treatments.

Presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and healthcare professionals.

The new webinars build on the success of ASBM and GaBI’s Summer 2022 webinars, the first of which looked at factors which contributed to successful biosimilar uptake in the U.S. and Europe and was the basis for a whitepaper in GaBI Journal’s Q4 2022 issue. The second examined the controversial policy of non-medical switching and its implications for patients, physicians, and the long-term sustainability of biosimilar markets; a whitepaper based on the meeting will be featured in the Q1 2023 issue of GaBI Journal.

More information on the IRA webinars will be available in the coming weeks.

On February 28th, ASBM and the Ontario-based International Foundation on Ageing (IFA) released the results of a new survey of Canadian ophthalmologists that documents these specialists’ views on biosimilars and substitution practices.

The survey’s release comes on the heels of Ontario’s recent announcement that it would begin force-switching patients with a variety of conditions from their physician-prescribed products to government-chosen biosimilars, beginning March 31st.

The survey of 41 Canadian ophthalmologists, all of whom prescribe biologics in their practice revealed:

• 81% were not comfortable with a third party such as a government switching a patient’s medicine for non-medical reasons such as cost, as would occur under the Ontario plan.
• 90% said that having sole authority, with the patient, to decide which biologic medicine to use is very important or critical.
• 91% considered the ability to prevent a forced switch by a public or private payer very important or critical.

ASBM’s executive director, Michael Reilly, emphasized the stark contrast between Ontario’s plan and the more physician- and patient- centered substitution practices of Europe:
“The Ontario announcement cites 15 years of safe use of biosimilars in Europe as a justification for its forced-switching policy. What the success of biosimilars in European markets has actually shown is that countries need not sacrifice physician and patients’ choice to enjoy significant savings. Most European markets accomplish savings through competition between many reimbursed products, rather than forced switches. Patients and physicians in Canada deserve no less – yet they are increasingly seeing choice restricted rather than expanded. With the arrival of ophthalmic biosimilars, we see yet another group of physicians and their patients expressing concerns with unnecessary switching in pursuit of short-term savings.”

Seventy-eight percent of survey respondents said their patients would be best served by a European-style scenario where multiple products including innovator and biosimilars are reimbursed, with biosimilars encouraged for new patients but no automatic substitution.

Only 15% preferred a system similar to that of Ontario where only government-chosen biosimilars are reimbursed, new patients must be prescribed these products, and current patients are forced to switch.
Read the press release about the survey here.

View the full ophthalmologist survey here.

On February 28, IQVIA held a webinar entitled Biosimilars in the United States 2023-2027. The webinar featured findings from the recently-released report of the same name. Among the report’s key findings:

• The U.S. biologics market has grown 12.5% annually on average over the last five years on an invoice-price basis, faster than non-biologics, and now comprising 46% of spending.
• Recent biosimilars have achieved high volume shares, reaching more than 60% of the molecule’s volume within the first three years. Non-340B clinics have seen higher uptake of biosimilars than 340B clinics, likely due to reimbursement dynamics.
• The three molecules with biosimilar launches in 2019 — bevacizumab (82%), trastuzumab (80%), and rituximab (67%) — achieved significant uptake within the first three years. It is unclear if uptake of these recent oncology biosimilars is indicative of future biosimilar uptake, however, these have gained higher market share than earlier biosimilars in the U.S. and are similar to or higher than rates of uptake in Europe.
• Pegfilgrastim and epoetin alfa biosimilars, both launched in 2018, have seen moderate uptake achieving 37% share of molecule volume in the first three years. Pegfilgrastim biosimilar share has continued to rise slowly while epoetin alfa biosimilar share has fallen to 27% as of October 2022.
• Infliximab has seen the lowest adoption of biosimilars, with volume share at 3% after one year and rising slowly to 13% after three years. This has shifted significantly in more recent years as biosimilars now account for 44% of infliximab volume nearly six years after biosimilar entry.

The presentation was followed by a panel discussion featuring Sameer Awsare, MD, Associate Executive Director, the Permanente Medical Group; Alex Brill, MA, CEO, Matrix Global Advisors, Luke Greenwalt, MBA VP and Lead, Market Access Center of Excellence, IQVIA; Chad Pettit, MBA, Executive Director, Marketing, Global Biosimilars Commercial Lead, Amgen; Marta Wosinska, Ph.D. Visiting Fellow, The Brookings Institution; Murray Aitken, Executive Director, IQVIA Institute for Human Data Science; and Michael Kleinrock, Research Director, IQVIA Institute for Human Data Science.

Read the full report here here. 

View a recording of the webinar here. 

On February 28th, the U.S. Food and Drug Administration and the Federal Trade Commission released two documents related to biosimilars and interchangeable biosimilars – an educational resource for consumers and patients and a summary report from the 2020 public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.”

Three ASBM representatives participated in the joint FDA/FTC: Immediate Past Chair Madelaine Feldman, MD; Advisory Board Chair Schneider, FASHP FFIP and Andrew Spiegel provided comments at the meeting.

One presenter identified the chief barriers to biosimilar uptake as physicians (who needed educational outreach to increase their familiarity and comfort with biosimilars) and payers (whose policies can sometimes impede utilization, and need to be addressed). ASBM Advisory Board Chair Philip Schneider addressed these concerns in his remarks at the workshop:

Our recent survey of 579 European biologic prescribers shows high knowledge and high confidence in biosimilars. Depending on country, between 82% and 93% of prescribers considered themselves familiar or very familiar with biosimilars. Between 80% and 99% would feel comfortable prescribing a biosimilar to a new treatment-naïve patient. Between 46-76% would be comfortable switching a stable patient.

if the premise behind today’s proceedings is valid – that biosimilar uptake is strongly tied to physician confidence, the high physician confidence in biosimilars across the board should correlate with a consistently high uptake across the board.

Yet if we look at the biosimilar market shares across the six countries we surveyed, there is a wide variation among biosimilars in different product classes. For example, market share for the Epoetin biosimilar ranged from 6-84%.  There are similar ranges for other biosimilars.

Clearly there are other factors besides physician confidence, which is uniformly high across the countries. These factors likely include differences between each country’s payer policies, differences in the length of time a biosimilar has been on the market, the number of biosimilars in a given product class, the discount of each product relative to the originator product, and other factors.

Read the testimony and comments provided to the FDA/FTC by Dr. Feldman, Dr. Schneider, and Mr. Spiegel.

Read the Summary Meeting Report here.
Read the FDA’s Educational Resource on Biosimilars here.
Visit www.fda.gov/biosimilars for more resources and information about biosimilars.

According to a study released in February by Cardinal Health, while most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.

As reported in Medscape Medical News, the new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice.

Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.

There are several reasons why a rheumatologist may be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told Medscape Medical News in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”
Read the full Medscape Medical News article here. (free signup required)

Read a Healio article breaking out the rheumatologist responses in the Cardinal survey here. 

Read it Here.

Festival of Biologics 2022 USA

San Diego, CA – March 20-22, 2023

WHO 76th INN Consultation

Geneva, Switzerland – March 28, 2023

DIA Global Annual Meeting

Boston, MA – June 25-29, 2023