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Strategic and Tactical Decisions for Long-Term Success

January 24-25, 2017
  • Alexandria, VA

Mitigate Risk — Navigate Evolving Regulations — Accelerate Market Access

— IN THE NEWS — January 17, 2017 — The FDA’s Draft Guidance for Industry was released on Jan. 17, 2017 on Considerations in Demonstrating Interchangeability With a Reference Product. This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purpose of submitting a marketing application or supplement under section 351(k) of the PHS Act. January 13, 2017 — The FDA’s Guidance for Industry was released on Jan. 13, 2017 on Nonproprietary Naming of Biological Products. This guidance describes the FDA’s current thinking on the need for biological products licensed under the PHS Act to bear a nonproprietary name that includes an FDA-designated suffix. December 28, 2016 — The FDA's Guidance for Industry was released on Dec. 28, 2016 on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. This guidance is intended to assist pharmaceutical and biotech manufacturers in developing clinical pharmacology programs to support a decision that a proposed biosimilar is not meaningfully, clinically different from a reference product.

With the first four U.S. biosimilars approved and many more in the FDA pipeline, it is critical that pharmaceutical companies develop strategies at a business operations level to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. At CBI’s 12th Biosimilars Summit, you’ll gain insights from industry experts on the tools and strategies needed to prepare for the impending changes impacting all elements of the healthcare industry.

CLE/CPE
CREDITS
AVAILABLE Pending Approval

Hear insights from key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers and patient advocates addressing everything from navigating impending regulations, determining optimal pricing models, accelerating market access strategies and executing strategic, long-term decisions to mitigate risk and build for success.

Join us to explore the current global climate for biosimilars business, evaluate competition and benchmark with industry peers on how to navigate the changing regulations and landscape of the biosimilars market to effectively bring these products to market.

GAIN CRITICAL INSIGHTS ON THE EVOLVING U.S. BIOSIMILARS LANDSCAPE:

  • Navigate key differences with interchangeability at the hospital or IDN level versus retail pharmacies
  • Discuss payer perspectives on physician education to determine initiatives to stimulate payer uptake
  • Reconcile internal competition to optimally promote and provide resources to all products, including novel therapeutics and biosimilars
  • Deep-dive into the naming debate around proposed suffix convention to differentiate among non-interchangeable biosimilars and its impact on track and trace processes
  • Asses the impact of the J-Code system on reimbursement decisions to focus solely on price rather than indications or quality

Gain a Sneak Peek of Insights from our Speaking Faculty To give you a preview of what is in store at the event, we asked a few of our speakers to share their thoughts on some of the hottest topics.

ACCLAIM FOR INDUSTRY’S MUST-ATTEND EVENT

‘Rookie’ or ‘Veteran’ in the biosimilars space, this conference allows you to gain some key learnings! It’s the great, intimate, professional setting to learn from esteemed colleagues, including potential competitors without risk!

Marketing, Merck

Eye-opening conference for every new person in biosimilars.

Regulatory Affairs, Amgen

Only CBI delivers consistent highquality panel discussions on USA biosimilar pathway policy and legal issues year after year after year!

Chairman, Harvest Moon Pharmaceuticals

An excellent blend of science, market dynamics, regulatory,
law and politics discussed by experts.

Director, Pfizer

January 24-25, 2017 Hilton Old Town Alexandria, VA

12th Biosimilars Summit

Strategic and Tactical Decisions for Long-Term Success

Mitigate Risk — Navigate Evolving Regulations — Accelerate Market Access

— IN THE NEWS — January 17, 2017 — The FDA’s Draft Guidance for Industry was released on Jan. 17, 2017 on Considerations in Demonstrating Interchangeability With a Reference Product. This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purpose of submitting a marketing application or supplement under section 351(k) of the PHS Act. January 13, 2017 — The FDA’s Guidance for Industry was released on Jan. 13, 2017 on Nonproprietary Naming of Biological Products. This guidance describes the FDA’s current thinking on the need for biological products licensed under the PHS Act to bear a nonproprietary name that includes an FDA-designated suffix. December 28, 2016 — The FDA's Guidance for Industry was released on Dec. 28, 2016 on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. This guidance is intended to assist pharmaceutical and biotech manufacturers in developing clinical pharmacology programs to support a decision that a proposed biosimilar is not meaningfully, clinically different from a reference product.

With the first four U.S. biosimilars approved and many more in the FDA pipeline, it is critical that pharmaceutical companies develop strategies at a business operations level to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. At CBI’s 12th Biosimilars Summit, you’ll gain insights from industry experts on the tools and strategies needed to prepare for the impending changes impacting all elements of the healthcare industry.

CLE/CPE
CREDITS
AVAILABLE Pending Approval

Hear insights from key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers and patient advocates addressing everything from navigating impending regulations, determining optimal pricing models, accelerating market access strategies and executing strategic, long-term decisions to mitigate risk and build for success.

Join us to explore the current global climate for biosimilars business, evaluate competition and benchmark with industry peers on how to navigate the changing regulations and landscape of the biosimilars market to effectively bring these products to market.

GAIN CRITICAL INSIGHTS ON THE EVOLVING U.S. BIOSIMILARS LANDSCAPE:

  • Navigate key differences with interchangeability at the hospital or IDN level versus retail pharmacies
  • Discuss payer perspectives on physician education to determine initiatives to stimulate payer uptake
  • Reconcile internal competition to optimally promote and provide resources to all products, including novel therapeutics and biosimilars
  • Deep-dive into the naming debate around proposed suffix convention to differentiate among non-interchangeable biosimilars and its impact on track and trace processes
  • Asses the impact of the J-Code system on reimbursement decisions to focus solely on price rather than indications or quality

Gain a Sneak Peek of Insights from our Speaking Faculty To give you a preview of what is in store at the event, we asked a few of our speakers to share their thoughts on some of the hottest topics.

ACCLAIM FOR INDUSTRY’S MUST-ATTEND EVENT

‘Rookie’ or ‘Veteran’ in the biosimilars space, this conference allows you to gain some key learnings! It’s the great, intimate, professional setting to learn from esteemed colleagues, including potential competitors without risk!

Marketing, Merck

Eye-opening conference for every new person in biosimilars.

Regulatory Affairs, Amgen

Only CBI delivers consistent highquality panel discussions on USA biosimilar pathway policy and legal issues year after year after year!

Chairman, Harvest Moon Pharmaceuticals

An excellent blend of science, market dynamics, regulatory,
law and politics discussed by experts.

Director, Pfizer

January 24-25, 2017 Hilton Old Town Alexandria, VA