Yusimry

Summary: Yusimry is the seventh FDA-approved version of adalibumab (reference product Humira®, manufactured by AbbVie).

Originally known as CHS-1420, Coherus BioSciences submitted a biologic license application to the Food and Drug Administration (FDA) for approval via the 351(k) biosimilar pathway in February 2021. The biosimilar was approved on December 20, 2021. The company plans to launch Yusimry in the US on or after July 1, 2023, per the terms of an agreement with AbbVie. Under the terms of the agreement, Coherus will pay royalties to AbbVie on sales of Yusimry.

Coherus BioSciences, located in Redwood City, California, is a commercial stage biopharmaceutical company that was founded in 2010 to develop and manufacture biosimilars. However, the company has expanded its portfolio to nonbiosimilar agents as well. A collaboration with Junshi Biosciences was announced in February 2021 to build its immune-oncology franchise. Currently, Coherus markets a pegfilgrastim biosimilar (Udenyca) and currently has biosimilars for ranibizumab and bevacizumab in development.

Like its competitors, Yusimry is not yet available on the US market because of licensing agreements signed with AbbVie, the manufacturer of the reference product Humira. In addition to the 7 adalimumab biosimilars approved by the FDA (including at least one interchangeable product), an additional 3 are expected to be ready to launch by the end of 2023. It should be noted that these biosimilars vary somewhat by formulation (citrate-free/non-citrate free, high-concentration/low-concentration, needle size).

ADALIMUMAB BIOSIMILARS IN DEVELOPMENT

(March 14, 2022) The infusion of competition into the adalimumab category will pretty much guarantee one concern will be true—the need for health systems and specialty pharmacies in particular—to stock virtually all brands, reference and biosimilars. The reason is simple: Different insurers will cover a range of products.

(March 1, 2022) Pfizer announced on February 25 that the Food and Drug Administration had accepted a supplemental 351(k) application for its adalimumab biosimilar Abrilada™, in an attempt to gain the interchangeability designation. This is just one development in clarifying the upcoming adalimumab interchangeability competition.

(January 10, 2022) In an effort to more closely match the options available with AbbVie’s reference product, partners Samsung Bioepis and Organon sent the US Food and Drug Administration a supplemental 351(k) application for a citrate-free, 100-mg/mL form of Hadlima™.

(December 23, 2021) On December 20, Coherus Biosciences announced that the Food and Drug Administration approved Yusimry (adalimumab-aqvh). This is Coherus’ second biosimilar approval. In 2017, Coherus completed a randomized, controlled phase 3 study involving 545 patients with moderate-to-severe plaque psoriasis, comparing the biosimilar to the reference product.

(November 16, 2021) At its third-quarter conference, Amgen announced that it is enrolling patients in a multiple-switching trial in an effort to obtain the interchangeability designation for Amjevita^®. Amgen’s phase 3 study began in early October and is scheduled to be completed in April 2023.

(October 18, 2021) On October 15, Boehringer Ingelheim formally secured its long-sought adalimumab interchangeability designation from the Food and Drug Administration (FDA). This label was earned based primarily on the results of Boehringer’s VOLTAIRE-X switching studies. The VOLTAIRE-X study demonstrated that patient efficacy or safety outcomes were not affected by multiple switches between Cyltezo and Humira^®.

April 21 2021) As we inch closer to the January 2023 date for the launch of the first US adalimumab biosimilar, industry watchers are more closely scrutinizing which company, if any, will have a competitive advantage in this lucrative marketplace.

(July 6, 2020) On July 6, the Food and Drug Administration approved partners Mylan/Fujifilm Kyowa Kirin Biologics’ biosimilar version of adalimumab for use in patients with autoimmune diseases.

(November 20, 2019) Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA).

(August 5, 2019) “Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

(July 24, 2019) In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira and Rituxan. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr).

(July 12,  2019) Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant, an approved Herceptin biosimilar.

(May 15, 2019) This agreement allows Boehringer Ingelheim to enter the marketplace July 1, 2023, getting a slight jump on some other licensees, but it effectively ends the protracted patent litigation that Boehringer hoped to win.

(January 28, 2019) At least 8 biosimilar manufacturers have signed licensing agreements with Abbvie, which allow immediate European launches for approved adalimumab biosimilars and sequentially timed US launches in 2023. This database displays the manufacturer, product name, and date of anticipated launch. Note: not all of these biosimilar adalimumab are approved in the US.

(January 28, 2019) Coherus becomes the eighth biosimilar maker to sign a licensing agreement with Abbvie, and it also becomes the first biosimilar maker to sue another (Amgen) for patent infringement.

(December 17, 2018) Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab.

(November 28, 2018)  Boehringer has now announced its intention to discontinue all efforts to market and develop any biosimilars outside of the US market.

(November 27, 2018)  According to the announcement, Pfizer will market this agent (PF-06410293), if approved by the Food and Drug Administration, in November 2023.

(November 1, 2018)  The Food and Drug Administration (FDA) announced yesterday the approval of adalimumab-adaz from Sandoz. The new agent, dubbed Hyrimoz™, will not be launched in the US until 2023.

(October 24, 2018) In part two and the conclusion of this interview, Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, speaks to Boehringer Ingelheim’s progress in Cytelzo interchangeability studies, its plans for the product in Europe in the face of several adalimumab biosimilars launches in the EU, and also the complexity inherent in CMS’s plans to move biologic agents from part B to part D coverage.

(October 23, 2018)  In the first portion of a two-part interview with Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, Boehringer Ingelheim, we cover the challenges of driving biosimilar uptake, as well as the unique situation that has focused this manufacturer’s attention on biosimilars and interchangeability.

(August 10, 2018)  Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.

(August 3, 2018) A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.

(June 22, 2018) In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval.

(April 6, 2018) Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023.

(February 5, 2018) AbbVie executives are sticking to their pledge to restrict annual price increases on Humira^® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market.

(January 16, 2019) Sandoz announced that it has thrown its hat in the ring for another Humira biosimilar.

(October 3, 2017) Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen-Abbvie agreement for the former’s adalimumab biosimilar is right out of this playbook.

(August 29, 2017) Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar.

(July 28, 2017)  One biosimilar developer announced on July 27 that it is embarking on a study specifically to prove interchangeability of its biosimilar version of adalimumab.

(July 12, 2017) FDA Advisory Committee members considered the data package provided by Amgen to be comprehensive, but the 26-0 vote was not without some interesting points and drama.

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