May 9th 2024
As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Revance Gives Mylan Additional Time to Decide on Botox Biosimilar Development
August 28th 2019In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).
Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39
July 16th 2019Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
Eye on Pharma: NeuClone to Start Phase 1 Trial of Ustekinumab Biosimilar
May 16th 2019NeuClone announced yesterday that it will initiate a phase 1 clinical trial of its ustekinumab biosimilar, referencing Stelara, in the second half of 2019. Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.
Study Reports on Physiochemical and Biological Characterization of Rituximab Biosimilar RTXM83
April 12th 2019While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.
Reference Infliximab and CT-P13 Show Similar Physicochemical and Functional Stability
April 11th 2019Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.
Are We Ready for Tailored Clinical Programs for Biosimilars?
March 29th 2019During 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 2019During 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 2019During 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.
Alvotech Enrolls First Patient in Phase 3 Study of Proposed High-Concentration Biosimilar Adalimumab
March 13th 2019Drug 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.
China Approves Its First Biosimilar, Henlius' Rituximab
February 27th 2019Regulators 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 2019Newly 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.
Eye on Pharma: Samsung Bioepis to Partner With C-Bridge on Biosimilars
February 11th 2019Biosimilar 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.
Could Aptamers Be a New Feature in the Biosimilar Developer's Toolkit?
February 6th 2019One emerging method to monitor potential differences is to apply aptamers: single-stranded DNA or RNA oligonucleotides. Aptamers can bind to various targets, and because they have a defined fold that can recognize a target with high affinity, they can be used as surrogate antibodies.
J&J and Biogen Discuss Their Biosimilar Strategies at J.P. Morgan Healthcare Conference
January 8th 2019Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.
The FDA Biosimilar Action Plan: Making Biologics More Accessible
December 7th 2018While other stakeholders also need clarification of the FDA policies, it is the developers who will make it possible to bring lower-cost biosimilars to make a real difference. In this paper, I am providing comments on the proposed action plans of the FDA and pointing out what I believe to be the missing elements.