Business

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Nielsen, a global measurement and data analytics company, recently revealed that direct-to-consumer healthcare advertising has reached 75% of US cancer survivors on television.

Biosimilar developer Alvotech and Fuji Pharma have entered into a partnership agreement for the commercialization of Alvotech’s entire pipeline of biosimilars in Japan, the companies announced this week.

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

The Center for Biosimilars® recaps the top news for the week of November 19, 2018.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Sandoz, a subsidiary division of Novartis, has launched its infliximab biosimilar, Zessly, in Germany. The launch brings the number of infliximab biosimilars available in Germany to 3.

Denmark’s national authorities have confirmed to The Center for Biosimilars® that AbbVie's Humira did not offer the lowest price for adalimumab in either of 2 national tenders.

A key factor in overcoming barriers to United States market entry is sharing the positive experiences of both healthcare professionals and patients, explained HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare during a presentation at SMi Biosimilars USA Conference in Iselin, NJ, that took place November 14-15, 2018.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.

During the first day of the SMi Biosimilars Meeting held in Iselin, New Jersey, from November 14-15, 2018, Christina Yunis, global biosimilars market development lead at Pfizer, discussed the sustainability of and challenges seen in the biosimilars market from an industry perspective.

Pfizer announced today that it has launched its epoetin alfa biosimilar, Retacrit, at a substantial discount to the reference product, Epogen.

Innovent Biologics, a China-based biopharmaceutical company, announced that its new drug application for its proposed adalimumab biosimilar IBI303, referencing Humira, was accepted by the National Medical Products Administration.

This week, healthcare economics stakeholders have gathered in Barcelona, Spain, for the 2018 annual European meeting of the International Society for Pharmacoeconomics and Outcomes Research. During the meeting, research teams from around the globe are presenting findings that support the use of biosimilar infliximab as a cost-saving measure.

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.

Genentech says that the biosimilar company benefited from its proprietary information, and a hearing is scheduled for December 13, 2018.

In its investor call on Thursday, Coherus Biosciences revealed that it will launch its biosimilar pegfilgrastim, Udenyca, at a 33% discount to the reference Neulasta.

The Center for Biosimilars® recaps the top news for the week of November 5, 2018.

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results.

Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.

At the Department of Abdominal Oncology at the National Cancer Institute of Naples in Italy, an expert pharmacist was involved in evaluating the economic impact of improving the Italian registry of high-cost drugs, particularly bevacizumab, cetuximab, panitumumab, and trastuzumab.

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

The Center for Biosimilars® recaps the top news for the week of October 29, 2018.

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.

In an interview with The Center for Biosimilars®, Imron Aly, JD, partner at Schiff Hardin LLP, explained that this long-running case to invoke sovereign immunity from inter partes review (IPR) carries important lessons for innovator product sponsors and generic and biosimilar developers as they consider IPR proceedings and the patent landscape as a whole.

US voters will head to the polls next week in the midterm elections, and in the run-up to the election, the Kaiser Family Foundation has revealed that pharmaceutical companies have donated nearly $79 million to members of Congress over the past 6 election cycles.