Business

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.

In total, income from Biocon’s biologics division was down 15% for the quarter (compared with the same period for the company’s prior financial year), despite the fact that product sales grew 16% year over year, with increased sales of insulins and biosimilar antibodies. The company’s total net profits declined by 46%.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 22, 2018.

Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.

Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.

Three drug developers have made recent strides forward with their biosimilars or proposed biosimilar referencing Enbrel (etanercept), with new product approvals, manufacturing developments, and growing sales.

The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.

The report from Trinity Partners details findings from qualitative research with 10 medical directors at US payer organizations, representing plans covering over 100 million commercial and Medicare enrollees in the United States.

Remicade earned approximately $1.47 billion globally in the fourth quarter of 2017, compared with $1.62 billion in the same period in 2016. The overall drop in Remicade sales included an 8.5% slide in US sales, a 5.5% increase in sales of US exports, and an 18.7% decline in international sales.

Japanese drug makers Kissei Pharmaceutical Company and JCR Pharmaceuticals have announced positive results of a phase 3 study for JR-131, a proposed biosimilar to darbepoetin alfa (Aranesp).

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.