Biosimilars are medicines that are highly similar, but not identical to biological medicines. Because of the uniqueness and complexity of biologics, biosimilars are NOT generic copies of biologic medicines. While there are a small number of biosimilars approved in other countries, there are no approved biosimilars in the U.S. until now. Biosimilars are under development and one will reach the marketplace in 2015 with others to follow. The U.S. Food and Drug Administration (FDA) accepted its first two applications for approval of a biosimilar.
As part of the Affordable Care Act (ACA), Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) establishing authority for FDA to review and approve biosimilars.
The BPCIA requires that a biosimilar be “highly similar” to an already-approved innovative biologic product and that “there are no clinically meaningful differences” between it and the reference product “in terms of the safety, purity, and potency of the product.”
The law also gives FDA authority to deem a biosimilar to be “interchangeable.” Interchangeability requires a significantly higher standard to confirm that an interchangeable biosimilar will achieve the same clinical result in any given patient.
The FDA has been developing processes and standards to review and approve biosimilars.
Key decisions, such as the kinds of studies that must be done and standards for biosimilars, have not yet been made. There are currently two draft guidance documents out for comment and more are expected.
This means we are at a critical time. FDA is expected to put forward biosimilar approval standards and consider approval of the first U.S. biosimilar against those standards in 2015.
Congress approved the BPCIA without extensive hearings as a part of the much larger ACA. No hearings were devoted to the safety of biosimilars prior to the approval of the legislation. The law left key details related to biosimilar review and approval to the discretion of the FDA.
While key Congressional leaders promised to hold a hearing on patient safety, Congress has yet to hold any oversight hearings regarding the BPCIA and biosimilar safety.
The complexity and uniqueness of each biologic medicine make it difficult to produce a biosimilar. A slight variation in the manufacturing can result in serious, life-threatening adverse events in our patients. It is imperative that the FDA ensure all biosimilars are thoroughly tested and meet the highest safety standards the same as all biologics are today. And it is crucial that the FDA get it right from the beginning. As we know, it is far easier to fix something before it takes effect than it is after the fact.
Given the significance of the decisions that will be made on a number of very important patient safety and access issues by FDA, we need a strong and united patient voice to be heard by policymakers at this critical time. We are concerned that without such an effort, a regulatory structure could be established and products approved and administered to patients without adequate patient protections in place. By putting forward a clear and strong patient advocacy voice, collectively we can make an important difference for our members and millions of Americans now and into the future.
July 12, 2016 50 State Network FDA Biosimilar Testimony - Global Healthy Living Foundation on behalf of the 50 State Network
Alliance for Patient Access (AfPA) chairman David Charles, MD discusses biologics and their impact on the future of healthcare - Alliance for Patient Access (AfPA)
First biosimilar approval leaves patient safety questions unanswered - Institute for Patient Safety
Georgia Takes A Stand
On March 25, 2015, Senate Bill 51 passed in Georgia. This bill protects patients and ensures physicians will determine whether a biosimilar is the best treatment for their patients. Rep. Sharon Cooper, Chair of the House Health and Human Services Committee, was instrumental in working with physicians, patients and patient advocates to pass this bill. ARxC and The Specialty Tiers Coalition of Georgia (STCGA) were engaged in this work.
March 25, 2015 - SB 51 is passed with a final vote by the Georgia Senate 43-3.
March 20, 2015 - SB 51 is adopted and passed by the Georgia House 162-0.
March 16, 2015 - We need your help to get Biosimilar Legislation passed! On , the House Rules Committee will consider whether or not to put SB 51 on the House floor for a vote . Senator Dean Burke will ask the House Rules Committee to put it on the calendar. It is crucial that SB 51 get out of the House Rules Committee.
We need everyone to contact via email and phone Rules Chairman John Meadows, Vice Chairman Rich Golick, Secretary Richard Smith, Speaker David Ralston, Speaker Pro Tem Jan Jones, House Majority Leader Larry O'Neal, Majority Whip Matt Ramsey, Minority Leader Stacey Abrams, and Minority Whip Carolyn Hugley to convey the importance of moving SB 51 to the floor for a vote.
March 9, 2015 - House Health & Human Services Committee (HHS) will hold a hearing on SB 51 at in room 606 CLOB at the State Capital (full agenda available here). Please call or email your Georgia Representative and the members of the Health & Human Services committee and ask them to support SB 51!
March 3, 2015 - HB 195 passed the Georgia House 165-0. It will now go to the Senate for assignment.
February 19, 2015 - SB 51 passed the Georgia Senate 47-1.
February 16, 2015 - This week, HB 195 and SB 51 unanimously passed out of their respective House and Senate Health & Human Services Committees. Both bills create a pathway for “Interchangeable Biosimilars” to be dispensed via substitution that includes communication between the pharmacist and physician.
HB 195 was before the House Rules Committee on Wednesday for consideration and was referred back to the House Health & Human Services based on concerns by two of the Rules Committee members who are both pharmacists.
SB 51 passed the Senate HHS Committee and will be eligible for the Senate Rules Calendar floor consideration next week.
ARxC and STC Principles
As patient advocates, our core concerns are to uphold safety and the physician-patient relationship. Physicians and their patients are in the best position to determine appropriate therapies. Transparency and communication between patients and their treatment teams is paramount.
The core principles that we believe should guide substitution policies for biosimilars under Georgia state law include:
a) Substitution should occur only when the FDA has designated a biologic product as interchangeable.
b) The prescribing physician should be able to prevent substitution.
c) The prescribing physician should be notified of any actions toward substitution within 24 hours.
d) The patient, or the patient’s authorized representative, should, at a minimum, be notified of any substitution within 24 hours.
e) The pharmacist and the physician should keep records of any substitution.
f) Biosimilars should stay in the traditional three tiers of the drug formulary which will ensure co-pays and co-insurance payments remain affordable to encourage compliance with treatment, preventing any compromise on the patients’ health and quality of life.