Policy

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

Evidence suggests that adoption of oncology biosimilars in Medicare value-based payment models has produced substantial cost savings and improved provider financial performance.

Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, easing concerns and highlighting nocebo challenges.

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps shape insulin product swaps.

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.

A new analysis dives into why Europe’s eye clinics lag on biosimilars and how education, guidance, and smarter tenders could unlock €747 million in savings.

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access.

Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets.

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.