- Decision not to review Federal Circuit July 2020 ruling
continues to prevent Sandoz launch of more affordable Erelzi
treatment option for US patients
- Sandoz is disappointed US patients affected by chronic
autoimmune and inflammatory disease have to wait until 2029 for
availability of biosimilar Erelzi
- Sandoz remains committed to pioneering access for patients and
contributing to more sustainable healthcare by launching biosimilar
and generic medicines
Basel,
Switzerland, May
17, 2021 – Sandoz, a
global leader in biosimilar and generic medicines, today announced
that the US Supreme Court has denied its petition to review the
Federal Circuit’s July 2020 decision concerning the Sandoz
biosimilar Erelzi® (etanercept-szzs) for reference medicine
Enbrel®* (etanercept). The Federal Circuit previously ruled against
Sandoz in a divided decision upholding Amgen’s patents.
“We are disappointed the Supreme Court decided not to review our
case,” said Keren Haruvi, President of Sandoz US and Head of North
America. “Today’s decision means Erelzi, a more affordable
biosimilar, will not be available to US patients with autoimmune
and inflammatory diseases until 2029; nonetheless we remain
committed to providing important treatment options for patients
affected by these diseases.”
With the trend towards increased spending on specialty medicines
only expected to grow,1 biosimilars play an important role in
enabling more patients to access biologic medicines and may offer
significant savings for patients, helping to alleviate the
overburdened healthcare system.2,3 Estimates suggest that a
biosimilar etanercept could have saved the US healthcare system
around USD one billion per year.4
Sandoz was the first company to receive approval from the US
Food and Drug Administration (FDA) for a biosimilar etanercept and
the first to launch a biosimilar medicine in the US. Erelzi has
been approved in the US for more than four years, since August
2016, however Sandoz has been unable to launch this medicine in the
US due to the patent litigation.
About biosimilars
A biosimilar is a successor to a biological medicine (known as
the “reference medicine”) for which the patent has expired and
exclusivity has been lost. Biosimilars have been shown to have
equivalent efficacy and comparable safety and immunogenicity.
Therefore, physicians and patients can expect the same clinical
outcome.
About Erelzi®
Erelzi is the Sandoz biosimilar of the reference medicine
Enbrel®. Erelzi has been studied in a global development program,
which included a comprehensive comparison of Erelzi and Enbrel® at
the analytical, preclinical, and clinical levels. The program
included preclinical studies, pharmacokinetic (PK) studies, and the
Phase III confirmatory safety and efficacy EGALITY study. Erelzi is
being studied in a real world setting through COMPACT, a global
non-interventional study conducted in countries such as Austria,
Canada, France, Germany, Italy, Poland, Spain, Switzerland and
United Kingdom. Erelzi is approved by the US FDA for the following
indications: adult rheumatoid arthritis (RA), ankylosing
spondylitis (AS), polyarticular juvenile idiopathic arthritis
(JIA), psoriatic arthritis (PsA) and moderate to severe plaque
psoriasis (PsO).
Erelzi® is a registered trademark of Novartis AG.
Important Safety Information
Please see full Prescribing Information for Erelzi here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761042lbl.pdf
Disclaimer
This press release contains forward-looking statements within
the meaning of the United States Private Securities Litigation
Reform Act of 1995. Forward-looking statements can generally be
identified by words such as “potential,” “can,” “will,” “plan,”
“may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look
forward,” “believe,” “committed,” “investigational,” “pipeline,”
“launch,” “reviewing,” “evaluating,” “ongoing,” “continues,” or
similar terms, or by express or implied discussions regarding
potential marketing approvals, launches, new indications or
labelling for Erelzi and the other investigational or approved
biosimilar products described in this press release, or regarding
potential future revenues from such products. You should not place
undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations regarding future
events and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Erelzi
or the other investigational or approved biosimilar products
described in this press release will be submitted or approved for
sale or for any additional indications or labelling in any market,
or at any particular time. Neither can there be any guarantee that
Erelzi will be launched in the US at any particular time, or at
all. Nor can there be any guarantee that Erelzi or such other
products will be commercially successful in the future. In
particular, our expectations regarding Erelzi and such other
products could be affected by, among other things, litigation
outcomes or other legal action, decisions or delays, including
intellectual property disputes or other legal efforts to prevent or
limit Sandoz from selling its products; the uncertainties inherent
in research and development, including clinical trial results and
additional analysis of existing clinical data; regulatory actions
or delays or government regulation generally; global trends toward
health care cost containment, including government, payor and
general public pricing and reimbursement pressures and requirements
for increased pricing transparency; our ability to maintain
proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; competition in
general, including potential approval of additional biosimilar
versions of such products; general political and economic
conditions; safety, quality, data integrity or manufacturing
issues; potential or actual data security and data privacy
breaches, or disruptions of our information technology systems, and
other risks and factors referred to in Novartis AG’s current Form
20-F on file with the US Securities and Exchange Commission.
Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic
pharmaceuticals and biosimilars. Our purpose is to pioneer access
for patients by developing and commercializing novel, affordable
approaches that address unmet medical need. Our ambition is to be
the world’s leading and most valued generics company. Our broad
portfolio of high-quality medicines, covering all major therapeutic
areas, accounted for 2020 sales of USD 9.6 billion.
Sandoz on social mediaLinkedIn:
https://www.linkedin.com/company/sandoz/Twitter:
https://twitter.com/sandoz_global Facebook:
https://www.facebook.com/sandozglobal/ Instagram:
https://www.instagram.com/sandozglobal CEO Richard Saynor on
LinkedIn: https://www.linkedin.com/in/richard-saynor/
*Enbrel® is a registered trademark of Immunex Corporation in the
US.
References
- IQVIA IMS Health and Quintiles. “Biosimilars: Who Saves?”.
White Paper. Available
at: https://www.iqvia.com/locations/united-states/library/white-papers/biosimilars-who-saves.
Accessed on March 29, 2021.
- IQVIA Institute for Human Data Science. Medicine use and
spending in the US: a review of 2017 and outlook to
2022. Available at:
https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022. Accessed
on March 29, 2021.
- U.S. Food and Drug Administration. Remarks from FDA
Commissioner Scott Gottlieb, M.D., as prepared for delivery at the
Brookings Institution on the release of the FDA’s Biosimilar Action
Plan [press release]. Available at: . Accessed on March 29,
2021.
- Data on file. US Healthcare Impact Biosimilar. Sandoz Inc.
March 2021.
###
Novartis Media RelationsE-mail:
media.relations@novartis.com
Julie MasowNovartis US
Communications+1 862 579 8456 (mobile)julie.masow@novartis.com |
Allison Schneider
Sandoz US Communications +1 609 619 9089
(mobile)allison.schneider@sandoz.com |
Chris
LewisSandoz Global Communications+49 174 244 9501
(mobile)chris.lewis@sandoz.com |
Michelle
BaumanSandoz Global Communications+1 973 714 8043
(mobile)michelle.bauman@sandoz.com |
Novartis Investor RelationsCentral investor
relations line: +41 61 324 7944E-mail:
investor.relations@novartis.com
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