JAMP Pharma Launches SIMLANDI™, a NEW High-Concentration, Low Volume, Citrate-Free formulation, Biosimilar to Humira®, in Canada

JAMP Pharma Launches SIMLANDI™, a NEW High-Concentration, Low Volume, Citrate-Free formulation, Biosimilar to Humira®, in Canada

SIMLANDI™ provides patients access to high-concentration, low volume, citrate-free formulations of adalimumab, in 40 mg/0.4 mL and 80 mg/0.8 mL presentations, not available in Canada before this week

SIMLANDI™ is the first adalimumab biosimilar product launched by a Canadian-based company, JAMP Pharma Group

The creation of BIOJAMP™ Pharma along with the introduction of the JAMPCare™ patient support program are designed to simplify the transition of patients to SIMLANDI™

BOUCHERVILLE, QCApril 13, 2022 /CNW/ – JAMP Pharma Group (“JAMP Pharma”), a Canadian-owned pharmaceutical company headquartered in the Montreal area, announced today the launch of SIMLANDI™, a high-concentration, low-volume, citrate-free, biosimilar to Humira® (adalimumab) developed and manufactured by Alvotech. The biosimilar, with its 100 mg/mL adalimumab in 40 mg/0.4 mL and 80 mg/0.8 mL presentations, is the first biosimilar candidate to be commercialized by BIOJAMP™, a biosimilar division of JAMP Pharma Group.

We are pleased to be the first Canadian company to offer adult patients in Canada access to a high-concentration, citrate-free form of adalimumab. SIMLANDI will also offer a unique 80 mg/0.8 mL dose that can reduce the number of starting injections by 50% for certain patients. This will be of particular interest to adult patients with conditions such as moderately to severely active ulcerative colitis and Crohn’s disease,” said Louis Pilon, CEO of JAMP Pharma Group.

It is with great pride that we announce our first BIOJAMP commercial launch.  This is a great milestone for the JAMP Pharma Group, it will help lower cost to the Canadian health care system and most importantly it brings added value to patients who will now have access to this high-concentration biosimilar of Humira®”, said Bruno Mader, COO of JAMP Pharma Group.

In January 2022, JAMP Pharma and Alvotech announced Canadian approval of SIMLANDI, a high-concentration biosimilar candidate to Humira® (adalimumab), which was developed under the name AVT02 by Alvotech.

SIMLANDI is a recombinant fully human immunoglobulin G1 (IgG1) kappa monoclonal antibody (mAb) that specifically binds to tumor necrosis factor-α (TNF) and blocks its interaction with the p55 (TNFR1) and p75 (TNFR2) cell surface TNF receptors, thereby neutralizing the effect of TNF in inflammatory conditions.

In February 2022, JAMP Pharma announced the creation of BIOJAMP™ as part of its goal to establish itself as a leader in the Canadian biosimilars market.  Both BIOJAMP™ and its JAMPCare™ patient support program are designed to simplify the process of transitioning to less costly biosimilar medicines.

About AVT02/SIMLANDI

AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab). AVT02 is not approved outside of the EU (Hukyndra®), Canada (SIMLANDI™), and the United Kingdom (Hukyndra®). AVT02 dossiers are under review in multiple countries; in the US the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspection(s). JAMP Pharma has exclusive commercialization rights to AVT02 in Canada under the trade name SIMLANDI.

In Canada, SIMLANDI has been authorized for sale for the following indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa, plaque psoriasis and adult and pediatric uveitis.

About JAMP Pharma Group

The JAMP Pharma Group is a Canadian-owned company headquartered in the Montreal area. Having experienced remarkable growth over the past 10 years, the JAMP Pharma Group is active in all segments of the pharmaceutical market with a portfolio of close to 300 molecules. The Group is among the industry leaders in terms of annual prescription volume1 and is the Canadian leader in product launches2. The Group also has a Wampole-Laboratoire Suisse Division with more than 180 over-the-counter products.

SOURCE JAMP Pharma Group

For further information: JAMP Pharma GROUP, Media Relations, Alexandra Lewicki, M.Sc, Director, Marketing & Communications, 514 238-6520, alewicki@jamppharma.com

(1)

Pharmaceutical manufacturers with the highest reported prescription volume in Canada from August 2018 to August 2021. Based in part on data obtained under license from IQVIA Solutions Canada Inc. on the following information service: CompuScript, August 2018 to August 2021. All rights reserved. This statement is not necessarily that of IQVIA Solutions Canada Inc. or any of its affiliates or subsidiaries.

(2)

Total number of notices of compliance (NOC), Health Canada, from April 1, 2020, to March 31, 2021. (Public information available at https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance.html)