Development

Are We Ready for Tailored Clinical Programs for Biosimilars?

March 29th 2019

By Kelly Davio

Article

During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.

An Expert View on Immunogenicity and Biosimilars

March 22nd 2019

By Kelly Davio

Article

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.

More Than a Decade After the First Biosimilar, the Regulatory Landscape Is Increasingly Complex

March 21st 2019

By Kelly Davio

Article

During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

Positive Results for Celltrion's Proposed Biosimilar Bevacizumab in Phase 1 Trial

March 15th 2019

By The Center for Biosimilars Staff

Article

According to the investigators, their data support the further development of CT-P16 as a bevacizumab biosimilar.

Alvotech Enrolls First Patient in Phase 3 Study of Proposed High-Concentration Biosimilar Adalimumab

March 13th 2019

By Kelly Davio

Article

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

Eye on Pharma: Mylan Could Develop the First True Botox Biosimilar

March 2nd 2019

By The Center for Biosimilars Staff

Article

Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.

China Approves Its First Biosimilar, Henlius' Rituximab

February 27th 2019

By The Center for Biosimilars Staff

Article

Regulators in China have approved the country’s first ever biosimilar, a rituximab product referencing Rituxan. The product, HLX01, was developed by Henlius and will be primarily used in the treatment of non-Hodgkin lymphoma. Regulatory requirements that were applied in the analysis of the drug, say investigators who took part in its development, will set a precedent for analytical similarity assessments of biosimilars in China going forward.

Study Reports on Analytical Characterization of Biosimilar Adalimumab SB5

February 23rd 2019

By Allison Inserro

Article

Newly published research reports on an analytical characterization of Samsung Bioepis’ biosimilar adalimumab, SB5, in comparison with the reference, Humira, using 3 different guidelines, showed that the 2 products are largely similar, and any of the minor differences are not clinically meaningful.

Study Finds Similar Long-Term Stability Between CT-P6 and Reference Trastuzumab

February 12th 2019

By The Center for Biosimilars Staff

Article

A recent study looked at the long-term stability of CT-P6, a trastuzumab biosimilar referencing Herceptin, to see if it had the same stability as the reference product.

Eye on Pharma: Samsung Bioepis to Partner With C-Bridge on Biosimilars

February 11th 2019

By The Center for Biosimilars Staff

Article

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced a new licensing agreement with the private equity firm C-Bridge Capital that will allow the drug maker to expand its reach into mainland China.