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CIMERLI® (ranibizumab-eqrn) Sales Exceed 100,000 Doses in First Year of Launch

Published: 2023-10-04 12:30:00 ET
<<<  go to CHRS company page

– CIMERLI®is the #1 ranibizumab biosimilar with 25% ranibizumab market share* –

– Demonstrated safety and efficacy in clinical trials and real-world settings –

– Robust and reliable supply addresses market need and expands anti-VEGF options across the retinal market –

REDWOOD CITY, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists have exceeded 100,000 doses since commercial launch on October 3, 2022. CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis® for all approved indications. In August 2023, CIMERLI® achieved 25% market share of the ranibizumab market*, making it the #1 ranibizumab biosimilar.

“Eclipsing 100,000 doses sold to retinal specialists within the first full year after commercial launch is an important milestone for CIMERLI® and reinforces the retinal community’s desire for a safe and effective biosimilar option to LUCENTIS®,” said Paul Reider, Chief Commercial Officer of Coherus. “Achieving 25% market share speaks to the strength of our commercial capabilities and replicates the success we saw with UDENYCA® in its first year on the market. We look forward to potential continued sales growth for CIMERLI® as more accounts continue their conversion.”

“Over the past twelve months we have launched three new products: CIMERLI®, the UDENYCA® auto-injector and YUSIMRY™. We now look forward to the potential approvals of two more products this year: toripalimab for nasopharyngeal carcinoma and the UDENYCA® on-body injector, and their subsequent launches,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus.

Coherus plans to report CIMERLI® net sales for the third quarter when the company reports Q3 2023 financial results in November.

About CIMERLI®CIMERLI® (ranibizumab-eqrn) is the only FDA-approved biosimilar interchangeable with Lucentis® for all Lucentis® FDA-approved indications. Formerly CHS-201 (also known as FYB201), it is a biosimilar to the reference product, U.S.-licensed Lucentis®. CIMERLI® has the same product attributes as 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) for CIMERLI® 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.

*IQVIA NSP Data August 2023.

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