Policy

Explore the safety and efficacy of switching to etanercept biosimilars, backed by clinical trials and real-world evidence for chronic inflammatory diseases.

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.

In 2025, the latest biosimilar policy developments included bipartisan efforts to enhance affordability and reduce barriers in the pharmaceutical landscape.

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape.

Biosimilar bevacizumab offers significant cost savings for Medicare, enhancing treatment access for metastatic colorectal and lung cancer patients without increasing spending.

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

UK neurologists release new guidelines for JC virus testing in patients using the natalizumab biosimilar Tyruko, addressing safety and monitoring challenges.

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability.

The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.

Biosimilar tocilizumab proves to be a cost-effective treatment for rheumatoid arthritis in Spain, enhancing access to advanced therapies.

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.

Australia's adoption of etanercept biosimilars enhances access to rheumatoid arthritis treatments, maintaining treatment persistence and patient care quality.

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for age-related macular degeneration and diabetic retinopathy.

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.

New denosumab biosimilars, Bildyos and Bilprevda, enhance access to affordable osteoporosis and bone disease treatments, promising significant patient benefits.

Canadian study reveals no significant differences in remission outcomes between etanercept biosimilars and the originator, Enbrel, for rheumatoid arthritis patients.

Patent thickets hinder biosimilar access, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake.

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

Biosimilars face a potential void as biologics lose exclusivity, prompting urgent calls for policy reform and enhanced education to ensure market sustainability.