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Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

Researchers based in the Republic of Korea have published data suggesting that they were able to produce a promising biosimilar obinutuzumab candidate from the plant Nicotiana benthamiana L. that is equivalent to obinutuzumab produced in glyco-engineered Chinese hamster ovary cells.

Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).

A recent research letter, published in the British Journal of Dermatology, reports that a biosimilar of etanercept, SB4 (approved as Benepali in the European Union and Brenzys in The Republic of Korea, Canada, and Australia), is associated with fewer injection-site reactions and less immunogenicity than reference etanercept (Enbrel), while maintaining equivalent efficacy.

MedPAC called for changes to Medicare Part D to remove the financial disincentives that block the use of lower-cost biosimilar therapies.

Rituximab is approved for use in hematological malignancies and in rheumatoid arthritis (RA), but is also used off-label in the treatment of antibody-dependent auto-immunological diseases. In off-label indications, alternative dosing schedules are sometimes used, though no dose-finding trials are available to help guide dosing in such diseases.

At this week’s 36th Annual J.P. Morgan Healthcare Conference, numerous biosimilar developers and reference product sponsors outlined their plans for the future. Our infographic provide 9 key takeaways.

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

Patients with rheumatoid arthritis (RA) who require a change in therapy from anti–tumor necrosis factor inhibitor (anti-TNF) treatments to biologics with a different mechanism of action (MOA) had higher treatment persistence and lower healthcare costs than patients who cycled anti-TNF drugs, resulting in lower healthcare costs per persistent patient among the MOA switchers, a recent study finds.

At the J.P. Morgan Healthcare Conference that took place this week in San Francisco, California, Republic of Korea-based biotech company Celltrion announced that it is preparing to build a new overseas production plant that will add to the strength of its biosimilar program.

On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 8, 2018.

At the J.P. Morgan Healthcare conference, Lupin Pharmaceuticals, a subsidiary of India-based Lupin Limited, announced biosimilar development plans for the company.

A review recently published in Lung Cancer: Targets and Therapy describes patient selection for treatment with bevacizumab, and argues that bevacizumab has a good safety profile in patient subpopulations previously considered ineligible for treatment with the therapy.

FDA Commissioner Scott Gottlieb, MD, has said that he is open to rethinking the aspects of a 35-year-old law that create incentives for drug companies to develop orphan drugs for rare diseases affecting fewer than 200,000 people, because the market has changed since the law was passed.

On the third day of the 36th Annual J.P. Morgan Healthcare Conference, Samsung Biologics, which forms Samsung Bioepis together with its partner Biogen, explained that its success is driven by short development timelines for its biosimilar products. Meanwhile, AbbVie, maker of the blockbuster Humira, featured its arsenal of products that could help insulate the drug developer from biosimilar adalimumab competition.

In an editorial that was recently published in Alimentary Pharmacology and Therapeutics, authors D. Sawbridge, MD, and S. Subramanian, MD, discussed how to mitigate primary nonresponse to infliximab.

Rituximab (Rituxan) is more effective and has lower rates of discontinuation than other disease-modifying treatments in newly diagnosed patients with relapsing-remitting multiple sclerosis, according to a Swedish study published online in the January 8, 2018, issue of JAMA Neurology.

During the second day of the 36th Annual J.P. Morgan Healthcare Conference, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar and follow-on competition.

In August 2017, Sandoz, a Novartis company, announced the launch of its etanercept biosimilar (Erelzi) in Canada. In December 2017, Ontario became the most recent Canadian province to add the biosimilar etanercept to its public drug plan for the treatment of multiple inflammatory diseases.

Intravitreal injection of bevacizumab (Avastin) has revolutionized the treatment of diabetic eye disease, and has emerged as an important treatment modality, either as primary or adjuvant therapy for diabetic macular edema and proliferative diabetic retinopathy.

Novartis announced today that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab (Cosentyx) versus a proposed biosimilar adalimumab (referencing Humira and being developed by Sandoz, a Novartis division) in patients with ankylosing spondylitis.

On the first day of the 36th Annual J.P. Morgan Healthcare Conference, biosimilar developers Coherus, Pfizer, and Teva all laid out their strategies for the year ahead.

In November 2017, the Federal Trade Commission (FTC) held a meeting, comprising industry groups representing generic and brand-name drugs, pharmacies, and pharmacy benefit managers, to discuss possible solutions to increase competition and lower the cost of drugs in the United States. Afterward, numerous stakeholders submitted comment letters to the FTC addressing competition issues.

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

Momenta Pharmaceuticals’ M923, a proposed adalimumab (Humira) biosimilar, showed bioequivalent pharmacokinetics (PK) and similar safety and tolerability to both EU- and US-licensed Humira in healthy subjects, according to findings from a phase 1 study published today in Pharmacology Research and Perspectives.

Writing in a Perspectives article, Michele K. Dougherty, PhD, and colleagues at the FDA predict the success of the agency’s biosimilars program and anticipate that as biosimilar development programs continue to mature, there will be an influx of biosimilar approval applications filed at the agency, and that the FDA and the biopharmaceutical industry will continue to build on the lessons learned from early biosimilar development programs.

The FDA approved a record-breaking 46 novel drugs in 2017. Our latest infographic breaks down the FDA's approval history for the last decase.

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb, Adaly, in the Indian marketplace this week, following Hetero's launch of Mabura.

This week, STAT held a webinar entitled "What to Expect in Biotech 2018." The broadcast was hosted by Adam Feurstein, a senior biotech reporter, and Damian Garde, a national biotech reporter. The goal of the webinar was to provide a framework of the themes that are likely to shape the biotech sector in the coming year, as well to provide a look at biotech stocks in 2018.