Development

Biosimilars Development Check-in: New Data for Celltrion, Samsung Bioepis Candidates

September 7th 2022

By Skylar Jeremias

Article

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Alvotech Brings in $40 Million in Revenue for First Half of 2022

September 5th 2022

By Skylar Jeremias

Article

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development

September 3rd 2022

By Deana Ferreri, PhD

Article

In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.

Dr Ivo Abraham Column: It's What We Do With the Savings—Economics and Equity

August 30th 2022

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.

Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

August 24th 2022

By Mary Caffrey

Article

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.

Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar

August 16th 2022

By Skylar Jeremias

Article

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Phase 1 Study Finds Similar PK Between Eculizumab Biosimilar, Soliris

August 13th 2022

By Deana Ferreri, PhD

Article

A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.

Q&A: How Will Biobetters Fit Into the Growing Biologics Market? Celltrion Executive Explains

August 6th 2022

By The Center for Biosimilars Staff

Article

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

Denosumab Biosimilar Demonstrates Noninferiority to Prolia in Postmenopausal Osteoporosis

July 30th 2022

By Deana Ferreri, PhD

Article

Results from a phase 3 trial suggested similar efficacy and safety of the denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.

Posters Assess Quality of Trastuzumab, Denosumab Biosimilars in Cancer

July 19th 2022

By Skylar Jeremias

Article

Posters from the American Society of Clinical Oncology’s annual meeting showed the safety and efficacy of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.