Biosimilars Bulletin | August 2020

News and Updates

Biosimilars Bring Value to Health Care

Given the vast amount of health care resources consumed by biologics, biosimilars are increasingly gaining attention as a viable option. As stakeholders evaluate biosimilars and their promised benefits, here’s a look at what biosimilars are bringing to health care today and the progress made so far.

Is the Biosimilars Waiting Game Finally Over?

Advocates say a number of regulatory changes could help bring more of these products to the market.

FDA Slashes Biosimilar Development Program Fees for Fiscal 2021

FDA plans to reduce fees for its biosimilar product development program in fiscal 2021 and to keep overall biosimilar user fee program and application fees at their fiscal 2020 levels, the agency announced. (Paid Sub. Req.)

Policies Targeting ‘Rebate Traps’ in Part D May Not Yield Big Savings, Study Suggests

Research on generic drug coverage in Medicare Part D plans finds access unobstructed for the majority of lower-cost alternatives. However, the study may offer an incomplete picture, generic and biosimilar advocates say. (Paid Sub. Req.)

Kashyap Patel, M.D.: A Champion for Biosimilars Uptake and Education

The Center for Biosimilars spoke with Kashyap B. Patel, M.D., about his work in promoting biosimilars uptake and his upcoming book on the importance of living life and not fearing death.

Two Efforts To Keep Payer Policies From Curbing Your Biosimilar’s Uptake

Ultimately, many physicians acknowledge that payer policies are their own animal and, in many cases, will be out of physicians’ control. But this does not mean that payer policies cannot be reshaped or that physicians cannot encourage greater biosimilar buy-in.

Automatic Substitution Pays Off for Compass Oncology West

Implementing automatic substitution, or therapeutic interchange, has increased access to biosimilars for patients at Compass Oncology West in northern Oregon, according to Lucy Langer, M.D., practice president and chair of the National Policy Executive Committee for The U.S. Oncology Network.

South Korea’s Celltrion, U.K.’s Intract Pharma to Co-Develop Oral Tablets in Infliximab

South Korea’s Celltrion Inc. has linked up London-based bio company Intract Pharma Ltd. to jointly develop oral infliximab tablets, which could be the world’s first pill-type biosimilar.

Association for Accessible Medicines Names New President and CEO

The Association for Accessible Medicines (AAM) Board of Directors have announced the appointment of Dan Leonard to be the association’s President and Chief Executive Officer.

Featured Resources

Infographic: Patients Have an Alternative to Expensive Biologic Medicines

Patients have an alternative to expensive biologic medicines. This new infographic highlights what patients need to know about biosimilars and how to increase access to these safe treatment options.

Infographic: Biosimilars Benefit Everyone

Biosimilars benefit everyone. This new infographic shows how we all — doctors, payers, and patients — can benefit from biosimilars.

Biosimilars in the Pharmacy Benefit Action Brief

This new resource from the National Alliance of Healthcare Purchaser Coalitions provides action steps for employers to drive biosimilar use and transparency.

The Importance of Countering Biosimilar Disparagement and Misinformation

A new white paper from Hillel Cohen, Ph.D. and Dorothy McCabe, Ph.D. finds biosimilar use is limited in some health care systems because biosimilars are not well understood by many health care professionals and patients.

Upcoming Events

GRx+Biosims 2020

November 9-11, 2020

For the first time ever, access the premier scientific and regulatory event for the generic and biosimilar medicines industry from the comfort of your home or office. Web stream the conference and get the information, insights and experience you expect from GRx+Biosims, plus participate in Q&A with speakers, have one-on-one meetings with exhibitors and network with peers.

Sign up now for the GRx+Biosims virtual conference.

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 23 percent of total drug spending. Additional information is available at www.accessiblemeds.org.