Policy

The FDA approved Teva's Degevma, a denosumab biosimilar to Xgeva for cancer-related bone disease, rounding out its Xgeva/Prolia portfolio.

The Association for Accessible Medicines report, prepared with the IQVIA Institute, also reports $25.4 billion in biosimilar savings for the year.

An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.

Congress advances biosimilar bills as new data emerge on romosozumab, tirzepatide, and ustekinumab biosimilar development.

Congress fast-tracks biosimilar bills to cut drug and insulin costs, while patent, rebate, and reimbursement roadblocks still stall competition.

Sandoz moves toward US generic tirzepatide autoinjectors as FDA reviews ANDAs, signaling future GLP‑1 access amid patent and biosimilar gaps.

Trial data show switching between ABP 654 and reference ustekinumab maintains similar psoriasis control, safety, and immunogenicity, supporting FDA interchangeability confidence.

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting access.

New EULAR guidelines speed RA treatment switches as rheumatoid arthritis biosimilars and cost savings push earlier biologics use.

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Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.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