Business

MJH Life Sciences™, owner of The Center for Biosimilars®, has acquired the Pharmacy Benefit Management Institute (PBMI), the nation’s leading provider of research and education that informs, advises, and influences the industry on drug cost management.

After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

The Center for Biosimilars® recaps the top stories for the week of March 23, 2020.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.

Teva Pharmaceuticals USA has filed suit in an attempt to use the expanded biologics licensure pathway as a way to hold back a potential competitor.

The FDA has approved a multidose vial of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which was first approved as a 150-mg single-dose vial in January 2019 and has yet to reach the US market in either form.

The Center for Biosimilars® recaps the top stories for the week of March 16, 2020.

Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.

Teva Pharmaceuticals USA and Celltrion Healthcare have launched the fourth trastuzumab biosimilar, Herzuma, at a 10% discount to the cost of reference product Herceptin.

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.