Policy

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

The Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.

Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.

Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.

A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.

The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.

Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.

Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.

Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.