Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

NovartisSandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.

"When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health." said Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz. "The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease."

Adalimumab is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis[1]. Rheumatoid arthritis alone affects approximately 1.5 million Americans with 200,000 new cases diagnosed each year[5], [6]. Women are disproportionately (3:1) affected by the disease[5].

The comprehensive data package submitted to the FDA, which comprises analytical, preclinical and clinical data, is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality. Clinical studies submitted to the FDA include a pharmacokinetic study in healthy volunteers and a Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS)[2]-[4].

Sandoz is committed to increasing patient access to high-quality biosimilars. As the global leader in biosimilars, Sandoz has five biosimilars marketed in various countries worldwide, as well as a leading global pipeline. Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

* Humira® is a registered trademark of AbbVie Biotechnology Ltd.

1. Humira® Highlights of Prescribing Information, 2002. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125057s232lbl.pdf . Last accessed December 2017.
2. Blauvelt A et al. A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.
3. Blauvelt A et.al. Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.
4. Jauch-Lembach J, et.al. Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.
5. Sholtzhauer, T.L. (2014). Living with Rheumatoid Arthritis. Available at: https://books.google.co.uk/books?id=ouURBAAAQBAJ&lpg=PR17&dq=200. Last accessed December 2017.
6. Arthritis Foundation. What is Rheumatoid Arthritis? Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Last accessed December 2017.

Most Popular Now

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

Sandoz Healthcare Access Challenge #SandozHACk ret…

Sandoz, the Novartis generics and biosimilars division, today announces the launch of the second Sandoz Healthcare Access Challenge (HACk). The #SandozHACk is a global co...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

Pfizer to award more than $3 million in grants to …

Pfizer Inc. today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants tota...

Novartis licenses three novel anti-infective progr…

Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug cand...

The Nobel Prize in Physiology or Medicine 2018 was…

Cancer kills millions of people every year and is one of humanity's greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor c...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

FDA approves expanded use of Gardasil 9 to include…

The U.S. Food and Drug Administration approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved...

DNA islands effective as 'anti-bacterial drones'

Genomic "islands" that evolved from viruses can be converted into "drones" that disable Staphylococcus aureus, bacteria that are often resistant to antibiotics and pose a...

FDA awards 12 grants to fund new clinical trials t…

The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to...

Pfizer announces Executive Leadership Team

Pfizer Inc. (NYSE:PFE) today announced its executive team that will report to Albert Bourla, incoming Chief Executive Officer, coincident with the commencement of his new...