REDWOOD CITY, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today announced that the company plans to launch YUSIMRY™ (adalimumab-aqvh) in July 2023* with a list price of $995 per carton (2 x 40 mg/0.8 mL autoinjectors), the lowest price announced to date of any adalimumab offering in the United States. With Humira® currently priced at $6,922 per carton of two autoinjectors, the YUSIMRY price will represent about an 85% discount from the originator.
YUSIMRY, a biosimilar of the reference product Humira® (adalimumab-injection) 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.
“Our YUSIMRY list price is a clear response to the challenges and needs of patients faced with high-cost adalimumab treatments today,” stated Denny Lanfear, Coherus CEO. “We believe there is a large, unmet need for improved access and affordability in the U.S. health care system that YUSIMRY can address with this pricing. Our excellence in manufacturing and supply chain management gives us the ability to deliver safe and effective biosimilar adalimumab at low cost with ensured, reliable supply.”
More than 300,000 patients in the U.S. take Humira each year, and Humira is among the top-selling drugs of all time, with 2022 net revenues in the United States of $18 billion.
The price of Humira has increased more than 500 percent since it was first launched in the U.S. in 2003 at $13,572 per year. The annual cost of Humira is now nearly $90,000, and the annual cost of YUSIMRY will be approximately $13,000, representing a discount of about 85%. In prior years, Coherus made significant investments in large-scale YUSIMRY manufacturing in order to be a high-volume, low-cost adalimumab producer. YUSIMRY has a state-of-the-art autoinjector presentation and includes Coherus’ proprietary non-stinging, citrate-free formulation and a 29-gauge needle.
“We believe that YUSIMRY can be an affordable solution for patients who are uninsured, underinsured, or recently separated from Medicaid coverage, who experience the most difficult financial health challenges. We also believe that employers and the employees on their health plans can experience significant savings by selecting YUSIMRY when it becomes available in July,” shared Chris Slavinsky, Coherus Chief Business Officer.
*No sales will occur, and no purchase orders will be accepted, until July 2023.
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).
What is the most important information I should know about YUSIMRY?
You should discuss the potential benefits and risks of YUSIMRY with your doctor. YUSIMRY is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking YUSIMRY if you have any kind of infection unless your doctor says it is okay.
What should I tell my doctor BEFORE starting YUSIMRY?
Tell your doctor about all of your health conditions, including if you:
Also tell your doctor about all the medicines you take. You should not take YUSIMRY with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).
What should I watch for AFTER starting YUSIMRY?
YUSIMRY can cause serious side effects, including:
Call your doctor or get medical care right away if you develop any of the above symptoms.
Common side effects of YUSIMRY include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with YUSIMRY. Tell your doctor if you have any side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:
YUSIMRY is given by injection under the skin.
This is the most important information to know about YUSIMRY. For more information, talk to your healthcare provider.
Uses
YUSIMRY is a prescription medicine used:
*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.
You may report side effects to Coherus BioSciences at 1-800-483-3692 or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Safety Information, please talk to your doctor and click for YUSIMRYTM 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 and the commercialization of our portfolio of FDA-approved therapeutics. 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.
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