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Four hospital groups, representing approximately 450 US hospitals, are planning to create their own nonprofit generic drug company in a bold move designed to address generic drug shortages and high prices affecting their hospitals.

On January 11, Celltrion and its partner Teva filed 2 new lawsuits against Genentech in a California district court.

Biosimilar developer Sandoz announced today that it has entered into a global partnership with India-based Biocon to develop, manufacture, and commercialize multiple biosimilars targeting immunology and oncology indications.

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).

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.

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.

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.

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.

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.

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.

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

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.

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 1, 2018.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti–vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.

Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.

Many drugmakers rang in the new year with increases in list prices of dozens of drugs that will take effect in 2018.

Israel-based Protalix BioTherapeutics has announced positive interim data from its phase 2 clinical trial of a proposed oral anti–tumor necrosis factor (anti-TNF) therapy, OPRX-106.

In 2017, the FDA more than doubled the number of drugs it approved compared with the previous year, with 46 novel medicines receiving the FDA’s endorsement in 2017.

Republic of Korea–based drug developer Polus has sold $9.37 million in convertible bonds to its affiliate Amnis.

A new paper argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems for biosimilars.

The Center for Biosimilars recaps the most-read articles of 2017.