YUSIMRY™ (adalimumab-aqvh) product image
–$995 per carton (two 40 mg/0.8 mL autoinjectors) represents a discount of more than 85% compared to Humira® –
– YUSIMRY™ meets high unmet need by providing patients, employers, physicians and payers with low-cost access to adalimumab treatment –
REDWOOD CITY, Calif., July 03, 2023 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that YUSIMRY™ (adalimumab-aqvh) is now available for commercial sale in the United States at a list price of $995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% to Humira® (adalimumab), currently priced at $6,922 per carton of two pens.
“Adalimumab products are important medicines for the treatment of serious autoimmune diseases, but cost is a barrier for many patients. With the launch of YUSIMRY, patients are now able to choose and access a high-quality, safe, and effective treatment at significant savings compared to Humira,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. “The price of Humira is nearly $90,000 a year today, putting this important therapy out of reach for many patients who are experiencing difficult financial health challenges. Our price for YUSIMRY of less than $13,000 a year was enabled by our investment in robust large-scale manufacturing, allowing us to be a high-volume, low-cost adalimumab biosimilar producer, ensuring reliable supply, and passing the savings directly to patients in need.”
YUSIMRY is presented in a state-of-the-art autoinjector and includes Coherus’ proprietary non-stinging, citrate-free formulation and a 29-gauge needle. YUSIMRY, approved in 2021 by the United States Food and Drug Administration (“FDA”), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. YUSIMRY Solutions™- Coherus’ patient services platform – will ensure improved access and a fast and seamless experience as patients start or switch to YUSIMRY treatment based on a determination by their healthcare provider.
About YUSIMRY
YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira® (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
YUSIMRY™ (adalimumab-aqvh) is biosimilar* to Humira® (adalimumab injection).
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete boxed warning.
Patients treated with YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue YUSIMRY if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients: 1. with chronic or recurrent infection; 2. who have been exposed to TB; 3. with a history of opportunistic infection; 4. who resided in or traveled in regions where mycoses are endemic; 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Do not start YUSIMRY during an active infection, including localized infections.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
CONGESTIVE HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
INDICATIONS
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of YUSIMRY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
Click for YUSIMRY™ Full Prescribing Information, including Boxed Warning and Medication guide
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.
In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. The Biologics License Application for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the launch date of YUSIMRY™ and expectations for the future price of YUSIMRY™.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance, or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to our existing and potential collaboration partners, the risks and uncertainties inherent in the clinical drug development process; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, the risk of FDA review issues; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023, filed with the Securities and Exchange Commission on May 8, 2023, including the section therein captioned “Risk Factors” and in other documents that Coherus files with the Securities and Exchange Commission.
UDENYCA®, CIMERLI® and YUSIMRY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.
Coherus Contact Information:
For Investors:
Marek Ciszewski, J.D., SVP Investor Relations
IR@coherus.com
For Media:
John Brandt, Rokk Solutions
coherus@rokksolutions.com
202-805-1830
Jodi Sievers, VP, Corporate Communications
media@coherus.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/34c5db37-10e4-460d-b799-803d209cdbbe
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