- Q-Code assigned to CIMERLI®for Medicare claims processing effective for dates of service on and after April 1, 2023 -

- COHERUS Solutions™ patient services hub is available to facilitate successful access and reimbursement-

REDWOOD CITY, Calif., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the Centers for Medicare and Medicaid Services (CMS) has published a new code pursuant to the Company’s application for Healthcare Common Procedure Coding System (HCPCS) Q-codes. The HCPCS Q-code assigned to CIMERLI® will be effective for patients administered CIMERLI® on or after April 1, 2023.

Paul Reider, Chief Commercial Officer of Coherus, said, "This is an important milestone in the CIMERLI® launch. Beginning April 1st, use of CIMERLI’s permanent, product-specific Q-code will enable more efficient billing processes and speed time to reimbursement for providers. We believe that Q-code utilization will serve as a catalyst for market conversion, accelerating growth in 2023 starting in the second quarter. We want to thank CMS for its consideration and timely review of our Q-code application.”

CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis® (ranibizumab injection) for all indications including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV). CIMERLI® is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation.1

Coherus Solutions™ offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance, industry-leading electronic services, and office support to ensure successful access and reimbursement.

About Q-Codes

Q-codes are permanent reimbursement codes granted to biosimilars and used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like CIMERLI® that are administered by a physician. Claims submission and documentation are simplified with a permanent Q-code, facilitating and streamlining the billing and reimbursement process.

About CIMERLI®

CIMERLI® (ranibizumab-eqrn) is the first and only FDA-approved biosimilar interchangeable with Lucentis® for all Lucentis® FDA-approved indications. CIMERLI® has the same product attributes with Lucentis®, in terms of dosage strengths (0.3 mg, 0.5 mg), formulation and excipients, and amino acid sequence. CIMERLI® was approved by the FDA on August 2, 2022. Coherus owns the biologics license application (BLA) and commercial rights in the U.S. and its territories. Coherus licensed CIMERLI® from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG.

1. CIMERLI® (ranibizumab-eqrn) U.S. Prescribing Information, August 2022.https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf

IMPORTANT SAFETY INFORMATION & INDICATIONS

CIMERLI® (ranibizumab-eqrn) is interchangeable* to Lucentis® (ranibizumab injection)

CIMERLI® (ranibizumab-eqrn), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)
• Myopic Choroidal Neovascularization (mCNV)

CONTRAINDICATIONS

• CIMERLI® is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS AND PRECAUTIONS 

• Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be utilized when administering CIMERLI®. Patients should be monitored following the injection to permit early treatment, should an infection occur
• Increases in Intraocular Pressure: Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI® and manage appropriately
• Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

Neovascular (wet) age-related macular degeneration

• The ATE rate in the 3 controlled neovascular AMD studies during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
• In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg ranibizumab compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)])

Macular edema following retinal vein occlusion

• The ATE rate in the 2 controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

Diabetic macular edema and Diabetic Retinopathy

• In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
• Fatal events in patients with diabetic macular edema and diabetic retinopathy at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded 

ADVERSE REACTIONS 

• Serious adverse events related to the injection procedure have occurred in