Business

Among the hottest topics in biosimilar development is the future of clinical trials, and that fact was evident during the opening session of the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom. During the presentation, a review of the biosimilar regulatory framework, 4 experts explained the ways in which the landscape for clinical trials is evolving for biosimilars.

On Friday, Mylan announced that it has launched its biosimilar adalimumab, Hulio, in the European Union. Hulio’s entrance into the marketplace brings the number of available biosimilar adalimumab therapies to 4.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

New research from Avalere suggests that moving Part B drugs into Part D could result in higher out-of-pocket costs for beneficiaries with rheumatoid arthritis (RA) unless policy changes are made to reduce Part D cost sharing.

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.

The Center for Biosimilars® recaps the top news for the week of October 15, 2018.

One day after Sandoz and Amgen announced European launches of their biosimilar adalimumab products referencing Humira, Samsung Bioepis announced that it has launched its own biosimilar, Imraldi.

“When we change the rules, the market players will reorganize their businesses to fit the new world. And it will be a very different world for American drug pricing," said HHS Secretary Alex Azar.

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom, and Amgen announced that it will begin making its Amgevita available in multiple European markets.

October 16 marks European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.

The Center for Biosimilars® recaps the top news for the week of October 8, 2018.

In June, the American Medical Association's (AMA) president Barbara L. McAneny, MD, outlined the group’s concerns during a hearing held by the California Department of Insurance stating that “The AMA has come to the conclusion that this merger would likely substantially lessen competition in many healthcare markets, to the detriment of patients,” and therefore should be blocked.

On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.

Coherus BioSciences has launched a comprehensive website offering patients and providers support services for its biosimilars.

As US healthcare increasingly moves toward value-based payment approaches, biosimilars, which reduce costs while maintaining treatment quality, can be an important driver of value. However, according to a white paper, a new framework for assessing the value of biosimilars is warranted.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech. The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018.

Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

Drug maker Alexion says that it is preparing for regulatory submissions in the United States, the European Union, and Japan for eculizumab (Soliris) for the treatment of anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.

Merck’s infliximab biosimilar, sold as Renflexis and approved by the FDA in April of last year, was determined to be the lowest priced infliximab option available to the US Department of Veterans Affairs (VA), and was awarded a national contract. Subsequently, it has become the sole infliximab product available on the VA's National Formulary.

The Center for Biosimilars® recaps the top news for the week of October 1, 2018.

The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.

“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.

Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.

The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.