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 <0.1% of intravitreal
injections, including endophthalmitis, rhegmatogenous retinal
detachment, and iatrogenic traumatic cataract
- In ranibizumab-treated patients
compared with the control group, the most common ocular side
effects included conjunctival hemorrhage, eye pain, vitreous
floaters, and intraocular pressure. The most common non-ocular side
effects included nasopharyngitis, anemia, nausea, and cough
- As with all therapeutic proteins,
there is the potential for an immune response in patients treated
with ranibizumab products. The clinical significance of
immunoreactivity to ranibizumab products is unclear at this
time
Postmarketing ExperienceThe following adverse
reaction has been identified during post-approval use of
ranibizumab products:
- Ocular: Tear of retinal pigment
epithelium among patients with neovascular AMD
*An interchangeable product (IP) is a biological product
that is approved based on data demonstrating that it is highly
similar to an FDA-approved reference product (RP) and that there
are no clinically meaningful differences between the products; it
can be expected to produce the same clinical result as the RP in
any given patient; and if administered more than once to a patient,
the risk in terms of safety or diminished efficacy from alternating
or switching between use of the RP and IP is not greater than that
from the RP without such alternation or switch. Interchangeability
of CIMERLI® has been demonstrated for the
condition(s) of use, strength(s), dosage form(s), and route(s) of
administration described in its Full Prescribing
Information
To report SUSPECTED ADVERSE REACTIONS, contact Coherus
BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
For additional Safety Information, please see
CIMERLI® Full Prescribing Information
available here.
About Coherus BioSciencesCoherus 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 and net sales; Coherus’
investment plans; Coherus’ ability to achieve approvals or launches
of any of its product candidates; and expectations about
maintaining or growing sales for any of Coherus’ products.
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, the risks and uncertainties inherent in the clinical
drug development process; risks related to integration of Surface
Oncology, Inc.’s programs and operations; risks related to Coherus’
existing and potential collaboration partners; risks of Coherus’
competitive position; the risks and uncertainties of the regulatory
approval process, including the speed of regulatory review,
international aspects of Coherus’ business and the timing of
Coherus’ regulatory filings; the risk of FDA review issues; the
risk that Coherus is unable to complete commercial transactions and
other matters that could affect the availability or commercial
potential of Coherus’ products and product candidates; 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 June 30, 2023 filed with
the Securities and Exchange Commission on August 2,
2023, including the section therein captioned “Risk Factors” and in
other documents 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 &
MediaJodi Sievers, VP, Corporate Communicationsir@coherus.com
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