Biosimilars Bulletin | June 2021

Each month, the Biosimilars Council sends a newsletter with the latest updates in the biosimilars industry, including policy movement, educational resources and upcoming events. To stay current on biosimilars, sign up to receive these monthly updates on the form to the right.

A Note from Biosimilars Council Executive Director Christine Simmon

This month, the Biosimilars Council took part in several important events, including a policy briefing with Rep. Kurt Schrader (D-OR) and the 2021 National Pharmacy Forum. In addition, new data continues to pour in proving once again that greater adoption of biosimilars provides significant savings for patients and health care providers. Lastly, we are so grateful for the positive responses we’ve received for the 2021 Voices of Access Report, which details how biosimilars are changing lives for the better.

To maintain this incredible progress, we need your help. Follow us on Facebook, Twitter and LinkedIn, share our latest resources, and join us at one of our upcoming events. With all of us engaged and active together, we can spread the word about the incredible benefits of biosimilars and make a real difference for patients across the country.

• Christine

News & Updates

Increasing Provider Reimbursement for Biosimilars Will Lead to Greater Adoption

Biosimilar competition has the potential to provide greater access to important treatments for America’s patients and cost savings for the nation’s health care system of as much as $130 billion by 2025. Biosimilars offer average cost reductions of 30% compared to the brands, but their adoption is lagging, due at least in part to misaligned provider reimbursement incentives. Fortunately, there are bipartisan solutions that would help to address this challenge.

Representatives Kurt Schrader (D-OR) and Adam Kinzinger (R-IL) have introduced the BIOSIM Act to encourage greater use of these novel therapies for life-threatening conditions such as cancer and chronic kidney disease. If signed into law, this bill will accelerate patient access to new lower-cost biosimilar treatments by providing a temporary payment increase to clinicians that prescribe them.

Pharmaceutical Pay-for-Delay Settlements “Have a Good Side”

“Pay-for-delay” settlements between originator companies and biosimilar developers have a bad reputation that may not be wholly deserved, said an intellectual property attorney at the American Conference Institute’s 12th summit on Biosimilars & Innovator Biologics. These agreements are now reviewed by the Federal Trade Commission (FTC), and there is evidence that they are better structured in recent years and play a constructive role in allowing competitor drugs to come to market sooner, said Karin A. Hessler, assistant general counsel for the Association for Accessible Medicines.

Obamacare Ruling Paves Way for Fixing Flaws in Biosimilar System

The Supreme Court’s decision to uphold Obamacare preserves a pathway for low-cost versions of biologic drugs to hit the market while also stirring a fresh debate over how to fix the system’s shortcomings.

The justices’ 7-2 decision “ensures America’s patients and taxpayers can continue to benefit from biosimilar access and competition in the marketplace,” Rachel Schwartz, spokeswoman at the Association for Accessible Medicines, said in a statement.

US Plays Catch-Up With Europe Over Biosimilar Patents

Europe’s more liberal approach to biosimilar drug patents is continuing to give it an edge over the US in producing lower cost medicines — despite moves by Washington to ease market access for generic manufacturers. US healthcare costs are significantly higher than Europe’s — the $11,000 spent per American in 2019 is more than double the amount per capita in France — with Europe’s wider availability of cheaper generic drugs, or biosimilars, a contributing factor.

Opinion: Biosimilars Offer Savings and Access for US Patients

All in all, these data underscore the value biosimilars provide to patients and our health care system. Biosimilar introduction facilitates lower prices of brand name biologics (reference products) and biosimilars in every class, so even patients who decide to stay on brand-name biologics benefit. In fact, biosimilar competition could help 1.2 million patients gain access to biosimilars or biologics by 2025. These innovative therapies have the potential to reduce overall spending on medicines by a staggering $100 billion in just 5 years.

Biosimilar Medicines Equal More Accessible Care for America’s Patients

The availability of biosimilars has meant that many patients affected by cancer, chronic kidney disease and other chronic conditions have now been able to access treatment they otherwise would not have received. These results support the Biosimilars Council’s previous findings that biosimilars would result in additional access to care for more than one million patients.

Ushering in the Next Wave of Biosimilars by Unlocking Their Potential

Sandoz recently collaborated with Reuters Events to bring together experts from patient organizations, healthcare (pharmacist), data science, and the pharmaceutical industry, for a live virtual discussion on the barriers to adoption of biosimilars worldwide and solutions that can improve access, affordability, and healthcare systems sustainability. Focus areas that emerged from the discussions included:

• Educating healthcare professionals and patients in a way that builds trust in and acceptance of biosimilars
• Implementing a multi-stakeholder (healthcare professionals, policymakers,  patient organizations, and payers) approach to drive availability and adoption of biosimilars

Pharmacist-Driven Biosimilar Adoption Model Leads to Cost Savings 

A community oncology practice facilitated substantial cost savings by effectively using biosimilars for brand-name drugs, according to a poster presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

“We should see significant savings in our value-based care models by the substitution that we were able to achieve,” Wilfong said. “And that’s on ASP alone. That doesn’t even include the ability to use multi-dose vials on these drugs instead of single-dose vials [for brand drugs].”Wilfong concluded that biosimilar conversion can be rapidly accomplished via a physician-approved, pharmacist-driven care team approach, with significant implications for the total cost of care and success in value-based care models.

FDA Accepts Application for Lupin Limited’s Pegfilgrastim Biosimilar 

“FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need,” Vinita Gupta, chief executive officer of Lupin Limited, stated in a press release. “This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.”

Experts Expect to See “Second Wave” of Biosimilars Approvals

Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges hobble uptake, according to presenters discussing the current landscape and future projections for the biosimilars market at the annual meeting of the Association for Accessible Medicines (AAM) on 27 May.

Biosimilars Adoption In Europe, US: Some Wins, ‘Incomplete’ Policies

Industry chiefs and experts, including Sandoz’ global head of biopharmaceuticals, deliberated at the recent AAM meeting the status of biosimilars adoption in Europe and trends and opportunities to generate savings for both the US federal government and payers.

Featured Resources

Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users

We also document that from biosimilar/follow-on products’ time of entry, their lower prices help offset the overall trend in average annual reference-product price increases. Our findings can provide insight into future policy reforms aimed at increasing competition and use of biosimilars, leading to expanded patient access and significant cost savings.

Upcoming Events

GRx+Biosims 2021 – November 8-10

GRx+Biosims 2021 is the premier scientific and regulatory event for the U.S. generics and biosimilars industry. With timely programming relevant to technical, regulatory and policy professionals, GRx+Biosims 2021 brings together top officials and subject matter experts to share their knowledge and best practices to enhance attendees’ understanding of generic and biosimilar development, regulatory process and approvals, and the evolving policy landscape.

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.

About AAM

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.accessiblemeds.org.