DIA’s Biosimilars Program Committee presents the first DIA Biosimilars Virtual Conference!

Created and curated by experts from our Biosimilars Program Committee, the DIA Biosimilars Virtual Conference is comprised of three sessions: Barriers to Uptake of Biosimilars in the US, Biosimilar Reimbursement in the US Marketplace, and Biosimilars in China. These sessions are available in  on-demand format, and can be enjoyed in the comfort of your home or office at your convenience.

To date, FDA has approved 10 biosimilars, yet only three are currently available on the market. Furthermore, in the US and in other regions, uptake of biosimilars has been less than initially anticipated. The barriers to realizing the promise of biosimilars are numerous, and in the US extend to reimbursement policies. Global development has been slowed by prohibitive regulations and guidelines in some regions such as China.

DIA’s Biosimilars Virtual Conference presents three sessions (see below for featured topics) that will examine the forces influencing the future of biosimilars for stakeholders in the US – from global developers to healthcare providers to patients.

Experts will delve into the adaptation of the US biosimilars landscape to address uptake barriers in the US and explore the implications of recent reimbursement policies on biosimilar utilization. The impact of the changing China regulatory environment on the potential of biosimilars and opportunities for inclusion of that country as a target region for global development will be examined.

Barriers to Uptake of Biosimilars in the US

• Lack of understanding: Perception challenges and misinformation around safety, effectiveness, extrapolation, quality, and interchangeability
• Commercial challenges: Educating health system stakeholders, restrictive formularies, contracting, and rebates
• Legal challenges: Extensive patent estates, unresolved questions from BPCIA, and settlements between originator and biosimilar companies

Biosimilar Reimbursement in the US Marketplace

• Payments for biosimilars under Medicare Part B: J-code, pass-through, implications, and key outstanding issues
• Payments for biosimilars under Medicare Part D: Coverage gap, cost-sharing changes, implications, and key outstanding issues
• Biosimilars to be subject to changes to 340B drug pricing

Biosimilars in China

• Biosimilar market in China: Potential, changing regulatory environment, clearing hurdles, and reimbursement
• Overall regulatory strategy: Raising data standards and alignment with international requirements, CTA process and timeline, and MAA process and timeline
• China regulatory strategy for biosimilar development: Review of existing and newly issued guidelines, Phase 1 PK study requirements, Phase 3 clinical trial requirements, and more on biosimilar Avastin (bevacizumab) and Herceptin (Trastuzumab) clinical design, and review considerations and the technical requirements of acceptance of foreign clinical data (draft)