Development

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.

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.

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

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.

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.

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.

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.

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.

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.

One 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.

Drug maker Alvotech announced this week that it has raised $300 million, through a private bond offering, that it will used to continue its growth, refinance debt, and further develop its biosimilar pipeline.

A representative from Pfizer confirmed to The Center for Biosimilars® that the company has terminated 5 of its preclinical biosimilar programs after the results of the company’s annual investment review.

Swedish biotechnology company Xbrane Biopharma recently announced that it has submitted its first national Clinical Trial Application to the FDA seeking permission to begin the Xplore trial.

Presenters 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.

During the first day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, 2 major biosimilar developers gave a look at their strategies for 2019 and beyond.

While 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.

In recent years, spending on specialty drugs, including spending on a proliferation of orphan drugs that treat rare diseases, has raised concerns about sustainability of the healthcare system.

Among the hottest topics in biosimilar development is the future of clinical trials, and that fact was evident during the opening session of the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom. During the presentation, a review of the biosimilar regulatory framework, 4 experts explained the ways in which the landscape for clinical trials is evolving for biosimilars.