Release Details

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.

• Serious infections have happened in people taking adalimumab. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have been hospitalized or died from these infections. Your doctor should test you for TB before starting YUSIMRY, and check you closely for signs and symptoms of TB during treatment with YUSIMRY, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including YUSIMRY, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including YUSIMRY, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated early; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting YUSIMRY?
Tell your doctor about all of your health conditions, including if you:

• Have an infection, are being treated for infection, or have symptoms of an infection.
• Get a lot of infections or infections that keep coming back.
• Have diabetes.
• Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled to an area where there is more risk for getting TB.
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use YUSIMRY. Ask your doctor if you are unsure if you have lived in these areas.
• Have or have had hepatitis B.
• Are scheduled for major surgery.
• Have or have had cancer.
• Have numbness or tingling in the extremities, or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome.
• Have or had heart failure.
• Have recently received or are scheduled to receive a vaccine. YUSIMRY patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting YUSIMRY.
• Are allergic to rubber, latex, or any YUSIMRY ingredients.
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
• Have a baby and you were using YUSIMRY during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

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:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.
  

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:

• Fever, sweats, or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red, or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired
  

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:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. YUSIMRY can be used alone, with methotrexate, or with certain other medicines. YUSIMRY may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. YUSIMRY can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. YUSIMRY can be used alone or with certain other medicines. YUSIMRY may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if YUSIMRY is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat moderate to severe hidradenitis suppurativa in adult patients.
  

*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 YUSIMRY^TM 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

Source: Coherus BioSciences, Inc.