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With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

The Salt Lake Tribune is reporting that public employees in the state of Utah could be paid by their insurance plan to fill prescriptions for high-cost drugs in Mexico instead of in their local pharmacies.

In recent years, spending on specialty drugs, including spending on a proliferation of orphan drugs that treat rare diseases, has raised concerns about sustainability of the healthcare system.

NeuClone has announced the start of its first-in-human trial of a trastuzumab biosimilar in a phase 1 trial.

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

On Thursday, the Trump administration unveiled a new plan that it hopes will reduce Medicare’s costs for prescription drugs. Under the plan, announced by President Donald Trump in a speech made at HHS, CMS could set its prices for some drugs—including high-cost biologics—based on the prices paid in other nations.

The Center for Biosimilars® recaps the top news for the week of October 22, 2018.

This month, Maryland’s Attorney General Brian Frosh petitioned the Supreme Court to uphold the “first-in-the-nation” law against drug price-gouging.

Among European nations, Denmark has had some of the greatest success with leveraging biosimilars to reduce cost burdens on its healthcare system, and during the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom, stakeholders heard directly from Dorthe Bartels, MSc, on how Denmark has achieved its strong biosimilar uptake.

While it is indeed the case that the current administration has made drug pricing and biosimilars a priority, and while the Biosimilar Action Plan was hailed as a major step forward for biosimilars in the United States, “It’s not the only plan that’s going to exist,” said the FDA's Leah Christl, PhD.

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.