“It is absolutely safe for a patient to switch from a biologic to a biosimilar because their qualities are similar. They work for the same kind of condition and their purity is the same as they have been tested for the same kinds of conditions”
“We have studies from all over the world and we find that patients have the same kind of benefits whether they are on the original biologic or the biosimilar.”
– Sameer Awsare, M.D., Associate Executive Director, The Permanente Medical Group
“Biosimilars are growing their market share and leading to meaningful price erosion over time; with the more recent biosimilar launches showing a lot of success – reflecting perhaps the growing market sophistication of the biosimilar companies.”
– Scott Gottlieb, M.D., Former FDA Commissioner
“These medicines are pretty amazing…we need patients to be able to get the medicines they need.”
– Sarah Yim, M.D., Acting Director OTTB
“To facilitate the development of biosimilars, the FDA created a more expedited process for the approval of biosimilars a few years ago, in which emphasis is put on the molecular characteristics, structure, and the product’s biologic behavior in the patient. This should demonstrate that the biosimilar is highly similar to the original product without the additional cost of large, randomized, phase III trials.”
– Gary H. Lyman, M.D., MPH, medical oncologist, Fred Hutchinson Cancer Research Center
“…It’s important to note that a biosimilar drug is so similar, to the point where it has the same clinical effect. The same effectiveness and the same safety profile as the originator biologic.”
“Every biologic drug will vary from one to the next. That’s completely expected; however, every biological drug – again, originator or biosimilar – has to be manufactured to stay within very specific ranges for each parameter that’s being measured. That itself is linked to the safety and effectiveness of the drug. By staying within these pre-defined limits, and as monitored by the company and then the data reviewed by the FDA, patients can be assured that by taking a biosimilar the have the same outcomes as with the originator biologic.”
“It’s important to realize that interchangeability is a regulatory designation. It’s actually optional, because physicians – even without this interchangeability designation – have the ability to prescribe whatever product they want, including a biosimilar in place of a reference biologic.”
– Hillel Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz
“Patients and providers should know biosimilars are safe and effective…provide more treatment options…potentially lower healthcare costs.”
– Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, FDA
“The biosimilar advances have allowed us to not only continue to bring great clinical care, but to lower the cost thereof.”
–Tracy L. Bahl, CEO of OneOncology
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.
About AAM
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. Additional information is available at www.accesiblemeds.org.
The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:
February 3–5, 2024 | Amelia Island, MD
Access! 2025 will bring together policymakers, influential speakers and industry leaders to chart the future of generic and biosimilar medicines. Discussions center around the business, breakthroughs and politics that shape our industry. Register now