The Association for Accessible Medicines (AAM) and its Biosimilars Council are eager for the start of this year’s GRx+Biosims conference beginning Monday, November 4. Top officials and subject matter experts will share knowledge and best practices to enhance attendees’ understanding of generic and biosimilar development, regulatory process and approvals, and the evolving policy landscape.
This year, the conference will cover topics ranging from the vital role of education in driving biosimilar utilization to the importance of global regulatory harmonization. Sessions will allow attendees to dive deeper into challenges faced by the generics and biosimilars industry, and how those challenges can be overcome.
Here is a sneak peek at a few of the sessions offered at GRx+Biosims 2019:
- Commercializing Biosimilars: Discussion with Industry Leaders Hear from industry leaders on practical approaches to biosimilars commercialization and how the burgeoning biosimilar market offers increased competition and patient access to innovative and life-changing treatments.
- The Importance of Global Regulatory Harmonization for Biosimilars
As global regulatory authorities, including the World Health Organization (WHO), European Medicines Agency (EMA) and Food and Drug Administration (FDA), are moving to harmonize regulatory requirements to make the development of biosimilars more efficient, hear how these changes can increase patient access and bring down costs.
- Driving Biosimilar Utilization through Education
Stakeholder attitudes toward biosimilars continue to evolve as the body of data on their safety, efficacy and savings grows. Educating and communicating the important impact that biosimilars have on patient access and affordability is essential to drive greater utilization of these competitive products.
- Transition from BsUFA I to BsUFA II
Industry and FDA will discuss the progress and challenges during the transition from BsUFA I to BsUFA II, including the evolution of the biosimilar pathway from non-existent to where we find ourselves today.
- Payer Strategies to Drive Biosimilars Access and Savings
Brand biologic manufacturers employ all kinds of anti-competitive market access tactics to block biosimilars adoption. The good news is that many major U.S. payers and pharmacy benefit managers (PBM) have begun preferring biosimilars to their branded reference products. Hear from the payer community on how biosimilars drive savings for plans and patients.
- Biosimilars Action Plan Scorecard: Is FDA Helping Adoption?
The FDA’s Biosimilars Action Plan (BAP) was an ambitious and necessary step to ensure the continued development of the biosimilars market in the U.S. Hear from industry experts on whether the agency has met expectations set forth in the BAP or if more work is needed.
- Federal Focus on Biosimilars: Policy and Politics
The U.S. government wields a great deal of clout when it comes to driving the drug pricing conversation. Officials often use biosimilars as a talking point on lowering prescription drug costs. But their policies don’t always support their talking points.
- Biosimilar Product Development (BPD) Program: Experiences and Expectations
Hear from FDA and industry on their experiences over nearly a decade and expectations for the ever-evolving BPD Program.
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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.
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.accesiblemeds.org.