In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

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

Biosimilar denosumab offers significant cost savings and improved access to treatment, alleviating financial burdens in oncology care while enhancing patient outcomes.

Patients with Crohn disease report high satisfaction and minimal discomfort using the citrate-free biosimilar CT-P17, enhancing adherence to treatment.

New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced treatment effectiveness and stability.

FDA approves Poherdy, the first interchangeable biosimilar for pertuzumab (Perjeta), enhancing competition in HER2-positive breast cancer treatment.

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.

October 2025 marks a transformative period for biosimilars, with new FDA guidelines accelerating approvals and promising significant cost savings for health care.

New clinical data confirms Bmab 1200, a biosimilar to ustekinumab, offers equivalent efficacy and safety for treating moderate to severe plaque psoriasis.

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

A recent study reveals global regulatory inconsistencies in biosimilars, urging convergence to enhance access and savings for patients and health care systems.

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

Biosimilars revolutionize health care access in Latin America, offering cost savings and improved treatment availability for chronic conditions and oncology.

A new study confirms that biosimilar ranibizumab matches innovator Lucentis in treating myopic choroidal neovascular membrane, supporting cost-effective healthcare solutions.

Researchers report that biosimilar use was not influenced by disease type but correlated with treatment sequence, shorter disease duration, and female sex.

A new study reveals Stivant, a bevacizumab biosimilar, matches Avastin in safety and efficacy for treating retinopathy of prematurity in infants.

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

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions.

A review of the safety of biosimilar DMARDs during pregnancy reveals critical evidence gaps and the need for informed clinical guidance.

The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.

AVT06, a promising biosimilar to aflibercept (Eylea), shows comparable efficacy and safety for treating neovascular age-related macular degeneration (AMD), enhancing patient access.

Biosimilar approvals surge in the US and Europe, enhancing access to denosumab and aflibercept therapies while driving significant health care savings.