Safe Biologics

On August 26th, ASBM’s Advisory Board Chair Philip Schneider gave a series of presentations at a Biosimilars Forum hosted by the Malta Medicines Authority in Valetta, Malta.

Dr. Schneider provided an extensive overview of multiple topics related to biosimilars, including:

• Biosimilars: General Concepts (20 min) View here
• Biologic Nomenclature and the Importance of Non-proprietary Names (20 min) View here
• Biosimilar Prescribing and Switching (20 min) View here
• Biosimilars: Economic Considerations/Pricing (20 min) View here
• Future of Biosimilar Market/long-term sustainability (20 min) View here

Dr. Schneider is a frequent lecturer in Malta on the subject of biosimilars. He has served for several years as an external examiner for Doctorate in Pharmacy final students at the University of Malta, and in July 2018 participated in a biosimilars seminar sponsored by the University of Malta, the Malta Medicines Authority, and the Malta Pharmaceutical Association.

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.”

The bill proposes to artificially incentivize biosimilar uptake by increasing reimbursement for biosimilars in Medicare Part B to ASP plus 8%, up from the current ASP plus 6%. This troubling proposal is not new, and has wisely been rejected by the Senate several times. In 2019 alone, this policy was defeated in the Prescription Drug Pricing Reduction Act, The BIOSIM Act (H.R. 4455) and The Lower Drug Costs Now Act (H.R. 3). From the letter:

We, the undersigned patient advocates and health care practitioners, have serious concerns with the potential negative impacts of this policy on patient care. It would create financial incentives for physicians to prescribe biosimilars; in effect, it would provide the doctor a 33% bonus for using a biosimilar instead of an originator product.

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies. We also firmly believe this proposal is unnecessary, misguided, and potentially harmful.

Read the full letter here. 

On July 28th, ASBM sent a letter to Congressional leaders expressing our  opposition to H.R.2815, the BIOSIM Act, a bill “to amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.”

The bill proposes to artificially incentivize biosimilar uptake by increasing reimbursement for biosimilars in Medicare Part B to ASP plus 8%, up from the current ASP plus 6%. This troubling proposal is not new, and has wisely been rejected by the Senate several times. In 2019 alone, this policy was defeated in the Prescription Drug Pricing Reduction Act, The BIOSIM Act (H.R. 4455) and The Lower Drug Costs Now Act (H.R. 3). From the letter:

We, the undersigned patient advocates and health care practitioners, have serious concerns with the potential negative impacts of this policy on patient care. It would create financial incentives for physicians to prescribe biosimilars; in effect, it would provide the doctor a 33% bonus for using a biosimilar instead of an originator product.

Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but the physician-patient relationship could be seriously undermined when physicians are rewarded financially for choosing one medicine over another. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally.

We share the goal of increasing biosimilar uptake and increasing patient access to biologic therapies. We also firmly believe this proposal is unnecessary, misguided, and potentially harmful.

Read the full letter here. 

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the need for prior physician authorization. The approval is a victory for patients and healthcare providers years in the making, according to the Alliance for Safe Biologic Medicines (ASBM). As the FDA press release states:

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

The FDA announcement comes on the heels of Oklahoma becoming the 50th and final state to permit substitution of interchangeable biosimilars this past April. As with similar laws nationwide, patients and the prescribing physician must be made aware of the substitution, and one may be prevented by the physician if deemed medically necessary.

“For eight years, patient advocacy organizations like ASBM worked with physician and pharmacist societies, manufacturers of both originator products and biosimilars, and state legislatures in fifty states to ensure that biosimilars could be safely substituted and patients nationwide could have access to lower-cost treatment options,” said ASBM’s executive director Michael Reilly.

ASBM’s efforts in this years-long campaign consisted of conducting three nationwide physician surveys, gathering dozens of patient testimonials, physician and pharmacist interviews, letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding educational forums at colleges of medicine and pharmacy.

Read more about the FDA’s approval here. 

On July 28th, the U.S. Food and Drug Administration (FDA) announced the long-awaited approved of the first interchangeable biosimilar, Mylan’s SemgleeⓇ. Under the Biologic Price Competition and Innovation Act (BPCIA) of 2009, which governs U.S. biosimilar development, an interchangeable biosimilar may be substituted in place of its reference product (in this case, Sanofi’s insulin glargine LantusⓇ) at the pharmacy without the need for prior physician authorization. The approval is a victory for patients and healthcare providers years in the making, according to the Alliance for Safe Biologic Medicines (ASBM). As the FDA press release states:

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

The FDA announcement comes on the heels of Oklahoma becoming the 50th and final state to permit substitution of interchangeable biosimilars this past April. As with similar laws nationwide, patients and the prescribing physician must be made aware of the substitution, and one may be prevented by the physician if deemed medically necessary.

“For eight years, patient advocacy organizations like ASBM worked with physician and pharmacist societies, manufacturers of both originator products and biosimilars, and state legislatures in fifty states to ensure that biosimilars could be safely substituted and patients nationwide could have access to lower-cost treatment options,” said ASBM’s executive director Michael Reilly.

ASBM’s efforts in this years-long campaign consisted of conducting three nationwide physician surveys, gathering dozens of patient testimonials, physician and pharmacist interviews, letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding educational forums at colleges of medicine and pharmacy.

Read more about the FDA’s approval here.