Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). The webinars will focus on unintended consequences for patient access that may result from the implementation of IRA provisions. The first webinar, entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines will be held in late June or early July (final date TBD).
Speakers will include:
The webinar will focus on the IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid to negotiate prices of certain costly drugs, including many biologic medicines. Webinar presenters will discuss cost containment efforts in different countries and examine the impact these policies have had on patient care and on the practice of healthcare professionals including physicians and pharmacists.
More information will be available soon.
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| Op-ed: IRA Drug Price Controls Will Hurt Cancer Drug Development
On May 18th, an op-ed by ASBM Steering Committee Member Andrew Spiegel ran in the Reading Eagle. Mr. Spiegel is a founding member of ASBM and Executive Director of the Global Colon Cancer Association. In the op-ed, Spiegel highlights the importance of small-molecule drugs in cancer therapy, and notes how the IRA disincentivizes their development:
We need more and better treatments, and we need them now.
Unfortunately, the new drug-pricing rules enacted in the Inflation Reduction Act will stymie efforts to develop new cancer treatments. Under the IRA, Medicare will be able to negotiate with drug makers for lower prices on an expanding list of brand-name medications. Drugs are divided into two categories: small- molecule drugs, which are chemical compounds typically available in pill form that patients pick up at the pharmacy and take at home; and biologics, which are extracted from living organisms and usually need to be administered by infusion or injection in a health care facility.
Both types of drugs are crucial to oncology treatment. Unfortunately, the IRA all but ensures that investment will pivot away from small molecule drugs towards biologics in the coming years. The IRA makes small molecule drugs eligible for price controls nine years after FDA approval — four years sooner than biologics.
Read the full op-ed here.
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ASBM’s Michael Reilly Participates in IFA’s Vision Health Month Webinar
As part of the celebration of the Vision Health Month, this webinar was executed to raise awareness on the importance of eye health, prevention of vision loss, and work to inform policies and practices underpinned with the principles of safe, effective and appropriate treatment, determined by the treating physicians in consultation with their patients.
A key policy issue discussed during the webinar was how Canadian provinces have been forcibly switching patients to biosimilars, and how this practice might affect patients on ophthalmic biologics. Mr. Reilly shared survey results from ASBM and IFA’s recent survey of 41 Canadian ophthalmologists regarding biosimilar substitution.
The survey revealed that 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 a recently-announced Ontario plan. 91% considered the ability to prevent a forced switch by a public or private payer very important or critical.
Seventy-eight percent of 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 Canadian provinces like British Columbia, Alberta, and Ontario where only government-chosen biosimilars are reimbursed, new patients must be prescribed these products, and current patients are forced to switch.
View the webinar here. |
| GaBI Journal publishes Whitepaper on Canadian Ophthalmologist Survey
On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). The paper is authored by IFA Secretary-General Jane Barratt and ASBM Executive Director Michael Reilly.
The survey revealed that 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 a recently-announced Ontario plan. Ninety percent of respondents said that having sole authority, with the patient, to decide which biologic medicine to use is very important or critical. And 91% considered the ability to prevent a forced switch by a public or private payer very important or critical.
Read the whitepaper here.
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| ASBM Chair to Present Poster Session at DIA Global Annual Meeting
On June 26th, ASBM Chairman Ralph McKibbin will present a poster session on ASBM’s Canadian ophthalmologist survey at the DIA Global Annual Meeting in Boston, MA. The survey’s findings were recently the subject of a whitepaper in GaBI Journal and were discussed at a webinar hosted by the International Federation on Ageing (IFA) which cosponsored the survey.
The DIA poster will compare the ophthalmologist survey findings with those of other physicians surveyed in recent years.
Ophthalmologists are just the latest group of physicians to raise concerns with the practice of forced switching. Prior ASBM surveys across many specialties revealed that 83% of Canadian, 82% of European, and 69% of U.S. physicians consider it very important or critical that the physician and patient control treatment decisions, including the decision to switch to a biosimilar. 79% of Canadian, 84% of European, and 67% of U.S. physicians considered the ability to prevent a substitution similarly important.
As we have done with previous posters presented at DIA Global Annual Meetings, ASBM will publish a video walkthrough of the poster for the general public following the poster session.
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