Process & Progress: A Recap of GRx+Biosims 2021

November 8-10, 2021, the Association for Accessible Medicines (AAM) and its Biosimilars Council hosted GRx+Biosims 2021, the premier scientific and regulatory event for the U.S. generics and biosimilars industry. The theme of this year’s virtual conference was “Process & Progress,” telling the story of where we are as industry and where we’re headed.

Over three days of panels, speeches and learning sessions, key policymakers and industry leaders shared invaluable insights that will drive the generics and biosimilars industry forward.

To kick off the conference, AAM CEO Dan Leonard delivered his State of AAM address, noting the role that all of us play in the health care system. We serve as the liaison between policymakers and regulators to ensure that processes work as they’re intended in order to achieve our shared goal of delivering a quality product at an affordable price to the American patient who depends on it, he told attendees. He went on to highlight the incredible savings generic and biosimilar medicines have generated, and he stressed that we must continue working to build a more favorable regulatory and policy environment to build on this progress.

Following Dan’s remarks, the conference featured a series of government decision-makers addressing the Administration’s priorities and achievements. Acting FDA Commissioner Dr. Janet Woodcock praised the work of the scientific community for creating safe and effective generics and biosimilars, but cautioned it's not enough just to have medical science breakthroughs if that science doesn't get translated into products that people can use.

She then outlined the FDA’s work to speed up product approvals and bring more lifesaving medicines to market, something AAM has worked diligently to facilitate.

CMS Center for Medicare Senior Advisor Kristi Martin stressed the importance of providing equitable, patient-centered care for beneficiaries, and she echoed President Biden’s recent executive order in noting that competition is one way to make drugs more affordable. She went on to outline key initiatives in Medicare Parts B and D to boost generics and biosimilars access as a means of reducing costs.

Day one also featured analysis from two leading specialists at the FDA. Jacqueline Corrigan-Curay, JD, M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research, noted that while the agency’s biosimilars approval program has grown considerably, there is still a lot of work to do to boost uptake and bring down the cost of biosimilar development.

Dr. Sarah Yim, Acting Director, Office of Therapeutic Biologics and Biosimilars (OTBB), summarized the rapid progress that was made to boost biosimilar uptake in the past year, and provided key insights into Biosimilar User Fee Amendments (BsUFA) and how we can enhance this process for future medicine developments.

Day two of the conference kicked off with keynote presentations from the heads of key departments at the FDA: Sally Choe, PhD, Director, Office of Generic Drugs, Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality and Donald Ashley, JD, Director, Office of Compliance (OC). They discussed a wide array of topics, including the resiliency of the generic drug market during the COVID-19 pandemic and the agency’s rigorous evaluation and review process ensuring every drug is safe and effective for patients.

Elizabeth Miller, PharmD, FDA Office of Regulatory Affairs, discussed how the pandemic impacted the agency’s operations, noting, “the current challenges have presented opportunities to reassess how we work, without compromising the integrity of our mission.” She then presented the agency’s Resiliency Roadmap, detailing the impacts of the pandemic and providing a blueprint for how to deal with future disruptions.

Ensuring the quality and safety of generic and biosimilar medicines is a top priority for our industry, and it was a key theme of our conference. Gerald Dal Pan, MD, Director, Office of Surveillance and Epidemiology, highlighted the innovative new Sentinel system, which is making evaluation more efficient and transparent so patients can trust the safety of their medicines. Ronald Piervincenzi, PhD, from U.S. Pharmacopeia (USP), discussed how USP’s rigorous quality control standards become even more critical during the pandemic, and how those standards are being used across the world.

In addition to keynote addresses from leading experts, GRx+Biosims 2021 featured a series of breakout panels. These panels followed either the Biosimilars Learning Track or the Science and Regulatory Learning Track, giving attendees the ability to engage with topics and experts most relevant to them and their companies. Topics covered included: generic drug clusters, streamlined biosimilar development, understanding regulatory requirements and strategies for communicating with the FDA.

Finally, attendees had the ability to attend informative roundtables hosted by AAM’s team of experts. AAM Executive Vice President and Biosimilars Council Executive Director Christine Simmon hosted the Manufacturer’s Roundtable with Council members to discuss the sustainability of biosimilar development in the evolving manufacturing environment. AAM Vice President, Policy, Craig Burton hosted a panel of experts discussing how to boost generics and biosimilars uptake through Medicare Part D.

We are deeply grateful for everyone who attended or spoke at GRx+Biosims 2021! By coming together, we are helping to strengthen the generics and biosimilars industry and provide even more savings for American patients.

For attendees, GRx+Biosims 2021 sessions are available on the GRx+Biosims 2021 virtual platform for replay until the end of February 2022. For those who missed that conference, reach out to Jennifer Soup for availability of sessions.


P.S. Access! 2022, AAM’s annual meeting, will be held in person February 14-16 in Orlando, Florida! For more information, click here.


Erica Klinger—Senior Director, Marketing

By Erica Klinger, Senior Director, Marketing
Published on November 29, 2021

Association for Accessible Medicines


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