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Moving Beyond Theory — Strategic and Tactical Decisions for Long-Term Success

January 23-24, 2018
  • Alexandria, VA
NEW FDA Draft Guidance —
Statistical Approaches to Evaluating Similarity for Biosimilars

The FDA released draft guidance on September 21, 2017 regarding information a sponsor should obtain about the structural/physiochemical and functional attributes of a reference products, how information is used in development of an analytical similarity assessment plan and statistical approaches recommended for evaluating analytical similarity. Review the draft guidance now.

Mitigate Risk — Navigate Evolving Regulations — Accelerate Market Access

As more biosimilar products continue to be added to the FDA pipeline, it is critical that pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. At CBI’s 13th 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.

Hear insights from key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers 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, evaluate competition and benchmark with industry peers on how to navigate the changing regulations and landscape of the biosimilars market and effectively bring these programs to market.

Hear Expert Insights On:

  • Critical updates on the latest FDA biosimilar guidance
  • Payer insights on leveraging interchangeability data, formulary placement and reimbursement
  • Biosimilar uptake and product switching policies across various care models
  • Stakeholder engagement and commercial potential through successful product marketing
  • State pharmacy law considerations and common differences between retail and hospital pharmacies
  • Patient journey for biosimilar drugs in EHRs to reduce overall cost of patient acquisition
  • HCPCS Biosimilar J-Codes impact on reimbursement and pricing
  • And more!

PLUS! Open our 2017 Biosimilars Time Capsule to compare last year’s conference predictions with actual 2017 market results and better prepare for upcoming changes in 2018.

Download the Conference Preview

Previous Attendee Acclaim:

Very good, well rounded and informative conference.

Regional Account Manager, UCB, Inc.

This conference has a great line-up of speakers and the conference atmosphere enabled excellent discussion.

Global Head Pricing, Market Access, and Policy, Biosimilars, Merck

‘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

Biggest takeaway – if I don’t know biosimilar ‘play,’ I am not alone. Intriguing discussion and open discussions.

Analyst, RAS Life Sciences

I enjoyed hearing talks about different aspects of biosimilars, along with discussions it helped me see how these things relate to one another and the overall impact on end users.

Specialty Pharmacist, UVA Health System

Eye-opening conference for every new person in biosimilars.

Regulatory Affairs, Amgen

January 23-24, 2018 Hilton Old Town Alexandria, VA

13th Biosimilars Summit

Moving Beyond Theory — Strategic and Tactical Decisions for Long-Term Success

NEW FDA Draft Guidance —
Statistical Approaches to Evaluating Similarity for Biosimilars

The FDA released draft guidance on September 21, 2017 regarding information a sponsor should obtain about the structural/physiochemical and functional attributes of a reference products, how information is used in development of an analytical similarity assessment plan and statistical approaches recommended for evaluating analytical similarity. Review the draft guidance now.

Mitigate Risk — Navigate Evolving Regulations — Accelerate Market Access

As more biosimilar products continue to be added to the FDA pipeline, it is critical that pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success. At CBI’s 13th 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.

Hear insights from key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers 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, evaluate competition and benchmark with industry peers on how to navigate the changing regulations and landscape of the biosimilars market and effectively bring these programs to market.

Hear Expert Insights On:

  • Critical updates on the latest FDA biosimilar guidance
  • Payer insights on leveraging interchangeability data, formulary placement and reimbursement
  • Biosimilar uptake and product switching policies across various care models
  • Stakeholder engagement and commercial potential through successful product marketing
  • State pharmacy law considerations and common differences between retail and hospital pharmacies
  • Patient journey for biosimilar drugs in EHRs to reduce overall cost of patient acquisition
  • HCPCS Biosimilar J-Codes impact on reimbursement and pricing
  • And more!

PLUS! Open our 2017 Biosimilars Time Capsule to compare last year’s conference predictions with actual 2017 market results and better prepare for upcoming changes in 2018.

Download the Conference Preview

Previous Attendee Acclaim:

Very good, well rounded and informative conference.

Regional Account Manager, UCB, Inc.

This conference has a great line-up of speakers and the conference atmosphere enabled excellent discussion.

Global Head Pricing, Market Access, and Policy, Biosimilars, Merck

‘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

Biggest takeaway – if I don’t know biosimilar ‘play,’ I am not alone. Intriguing discussion and open discussions.

Analyst, RAS Life Sciences

I enjoyed hearing talks about different aspects of biosimilars, along with discussions it helped me see how these things relate to one another and the overall impact on end users.

Specialty Pharmacist, UVA Health System

Eye-opening conference for every new person in biosimilars.

Regulatory Affairs, Amgen

January 23-24, 2018 Hilton Old Town Alexandria, VA