November 4-6, 2019 | North Bethesda, MD

Biosimilars Learning Track

GRx+BIOSIMS
BIOSIMILARS
LEARNING TRACK

Breaking Through on Biosimilars
Biosimilars are delivering on the tremendous promise of biologic medicines while providing patients with expanded access to lifesaving treatments. Join us as we drill down on the policy and regulatory challenges facing the U.S. biosimilars market.

GRx+Biosims Biosimilars Learning Track:

Commercializing Biosimilars: Discussion with Industry Leaders
What’s the current state of biosimilars? There’s plenty of promise with a growing number of U.S. launches that could lead to more than $54 billion in savings over the next decade, providing access to needed medicines for 1.2 million patients. But there are troubling signs on the horizon as well, including rebate and contracting tactics, IP, and regulatory issues that could block future progress. Finding your way in the biosimilars industry means understanding all the factors that come into play, recognizing the obstacles/pitfalls and adopting the practices that will give you the best chance to succeed. That’s why we’re bringing together insightful biosimilar industry leaders to lead a beneficial discussion on practical approaches to commercialization and how this burgeoning pharmaceutical market is a unique opportunity.

Commercializing Biosimilars: Discussion with Industry Leaders
What’s the current state of biosimilars? There’s plenty of promise with a growing number of U.S. launches that could lead to more than $54 billion in savings over the next decade, providing access to needed medicines for 1.2 million patients. But there are troubling signs on the horizon as well, including rebate and contracting tactics, IP, and regulatory issues that could block future progress. Finding your way in the biosimilars industry means understanding all the factors that come into play, recognizing the obstacles/pitfalls and adopting the practices that will give you the best chance to succeed. That’s why we’re bringing together insightful biosimilar industry leaders to lead a beneficial discussion on practical approaches to commercialization and how this burgeoning pharmaceutical market is a unique opportunity.

Biosimilars Action Plan Scorecard: Is FDA Helping Adoption?
A better understanding of how the FDA communicates and operates could mean the difference in getting a new biosimilars medicines approved or having them languish in development. We’re bringing together a seasoned group of FDA experts to lead a discussion on ways FDA policy is affecting both the U.S. and global biosimilars markets.

The Importance of Global Regulatory Harmonization for Biosimilars
Policies and regulations regarding biosimilars medicines differ from country to country, leading to confusion over biosimilars integrity. Global regulatory harmonization – the process by which technical guidelines are developed to be uniform across participating authorities – ensures consistency and affordability of biosimilars and their safety and reliability. Find out how these factors affect global development with a session that discusses how global regulatory authorities, including the World Health Organization (WHO), European Medicines Agency (EMA) and FDA, are moving to adopt global harmonization of regulatory standards to help expand patient access and bring down drug costs.

Payer Strategies to Drive Biosimilars Access & Savings
Brand-name drug companies are using every tool at their disposal to protect and extend the monopolies of biologic medicines. Their anti-competitive tactics are effectively blocking biosimilars adoption and denying access to affordable, lifesaving medicines to patients who desperately need them. The good news is that many major U.S. payors and pharmacy benefit managers (PBM) have begun preferring biosimilars over their branded reference products, and their voices are driving real change in the industry. Hear representatives from the payor community discuss how they’re overcoming obstacles and realizing significant savings for patients and the health care system.

Federal Focus on Biosimilars: A Lot of Bark and No Bite
The Biologics Price Competition and Innovation Act (BPCIA) was designed to accelerate approval of biosimilars medicines and provide more treatment options, increase access to lifesaving medications and lower health care costs for U.S. patients. Unfortunately, the U.S. government isn’t following up and doing all it can to promote and bolster biosimilars.

Hear from a broad stakeholder group on how the executive and legislative branches can incentivize the use of biosimilars and increase adoption.

Biosimilar Product Development (BPD) Program: Experiences and Expectations
Welcome to an inside look at the FDA’s biosimilar regulatory approval process. This comprehensive program was designed to encourage biosimilar competition by developing policies to increase product options, provide more access and deliver more safe, effective and lower-cost biosimilar alternatives to patients. We’re bringing together FDA officials and industry experts for an in-depth discussion on real-world experiences with the BPD program and ways to more successfully navigate the approval process.

Topics include:

  • Data and study requirements necessary to prove a proposed product is “biosimilar” to a particular reference product
  • Unexpected observations and obstacles encountered during BPD programs and how they were addressed
  • Steps companies have taken to create a global dossier
  • Development of new types of biosimilars (e.g. super-orphan biosimilars, ophthalmic biosimilars)
  • Final interchangeability guidance and FDA regulatory expectations
  • Implications of the transition of certain therapeutic protein products from the 505 approval pathway to the 351 approval pathway

Progress and Challenges of BsUFA II
We’re gathering industry and FDA representatives to evaluate of the progress and challenges of BsUFA II, which authorizes the FDA to collect fees and use them for the process for the review of biosimilar biological product applications.

Topics include:

  • Evaluation of metrics used for adhering to BPD meeting timing commitments
  • Review cycle of BPD programs; feedback provided to sponsors;
  • FDA staffing goals; FDA’s commitment to education related to biosimilars, status of guidance’s for which commitments were made.

This session will include an evaluation incorporating a “score card” of FDA commitments as well as a discussion of the financial health. If you’ve got questions about BsUFA II, this is the place to find answers.

Driving Biosimilar Utilization Through Education
How do stakeholders think and talk about biosimilars? Stakeholder attitudes continue to evolve as the body of data on their safety, efficacy and savings grows. Hear from panelists representing patients, providers and payors about how each is educating and communicating the important impact that biosimilars have on patient access and affordability in order to drive greater utilization of these lower-cost products.

Biosimilars at the Bar
Biosimilars have the ability to give patients much-needed access to lower-cost complex therapies. This session takes a deep dive on the themes that will shape the industry in months and years to come. Get the latest on legislation, litigation and the curiosities and complexities of the patent process, as well as other obstacles and opportunities for bringing more biosimilars to market.

Who should attend:

About GRx+Biosims 2019

GRx+Biosims 2019 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy and legal professionals. Top officials and subject matter experts share their knowledge and best practices to help attendees understand how to succeed in generic and biosimilar development, the regulatory process and approvals and the evolving policy landscape.

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Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.