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The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

Growing awareness of biosimilars, patent expirations, and demands to lower healthcare costs are combining to increase uptake over the next 3 to 5 years, according to a recent S&P Global Ratings report. Some pharamceutical firms stand to gain, while others are more exposed.

Both the capitalized research and development costs as well as the average cost of investments were higher than previous estimates from other researchers.

The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.

Although the US biosimilar market had a slow start, the booming industry in Europe shows the potential for the market here. However, in order to level the playing field, more policy changes and legislation are needed to prevent originator products from crowding out competitors.

Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.

Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.

Hurdles to a vibrant biosimilar market are not as insurmountable as they appear.

By 2023, patents on nearly 20 oncology biologics will expire, which could lead to more biosimilars in cancer care and therefore reduced costs, according to a review article.

Biosimilars are starting to gain some traction in the marketplace, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

Merck markets a biosimilar infliximab, Renflexis; a biosimilar trastuzumab, Ontruzant; and a biosimilar etanercept, Brenzys, in partnership with Samsung Bioepis.

Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

In case you missed it: Jeffery Scott, MD, chief medical officer of Integra Connect, discussed what role biosimilars will play in a value-based system on a recent podcast episode of Not So Different.

The company has recalled its employees from Wuhan until the outbreak is brought under control, as have many other outside companies and government agencies with workers in the Chinese market affected by the coronavirus.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

Molly Burich, MS, director of public policy for biosimilars and pipeline at the pharmaceutical giant Boehringer Ingelheim, discussed the International Price Index proposal Thursday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.

In a wide-ranging state-of-the-industry talk, the clinical operations manager for Blue Cross Blue Shield of Michigan discussed pending legislation, electronic prior authorization (ePA), and biosimilar uptake, among other prominent issues Wednesday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.

Health New England says it achieved 93% utilization by requiring prior authorization.

The company's announcement of an aggressive launch calendar at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.

The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.

The leading generic drug manufacturer launched Truxima, a biosimilar for rituximab, in November 2019 at a 10% discount to the reference product, Rituxan.

Gilead Science’s new chairman and chief executive officer outlined a growth plan this week at the J.P. Morgan Healthcare Conference in San Francisco, California.