Regulatory

Health Canada Approves First Omalizumab Biosimilar

December 16th 2024

By Skylar Jeremias

Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

November 26th 2024

By Ashling Wahner

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

November 21st 2024

By The Center for Biosimilars Staff

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

November 21st 2024

By Skylar Jeremias

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.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data

November 19th 2024

By Skylar Jeremias

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

Can Global Policies to Boost Biosimilar Adoption Work in the US?

November 17th 2024

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.

BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?

November 4th 2024

By Sarfaraz K. Niazi, PhD

The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.

Enhancing Adoption of Infused Biosimilars for a Sustainable Future

October 30th 2024

By Skylar Jeremias

An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.

Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf

October 25th 2024

By Skylar Jeremias

At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.