On June 9, 2016 Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, reported results from two key studies comparing its biosimilar etanercept and rituximab candidates with the originator products – Enbrel*** and MabThera**** respectively (Press release, Novartis, JUN 9, 2016, View Source [SID:1234513158]). In both studies, the primary endpoints of achieving PK bioequivalence were met. The studies were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.[1],[2] Etanercept and rituximab are indicated to treat autoimmune diseases such as rheumatoid arthritis. Rituximab is also indicated to treat hematological cancers like follicular lymphoma. Schedule your 30 min Free 1stOncology Demo! "Findings from these studies, along with additional data in our development programs, demonstrate that our biosimilar etanercept and rituximab candidates are highly similar to their originators," said Malte Peters, Head Global Clinical Development, Biopharmaceuticals, Sandoz. "Access to biological therapies remains a challenge for many patients with immunological disorders such as rheumatoid arthritis and blood cancers like follicular lymphoma. If approved, our biosimilars could help broaden access to these vital therapies."
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The Phase I etanercept trial demonstrated PK bioequivalence and no clinically meaningful differences in safety, tolerability and immunogenicity between the biosimilar candidate and the etanercept originator product (Enbrel).[1] No major safety signals were observed during the study.[1]
The Phase II rituximab trial demonstrated PK bioequivalence and similar PD, safety, efficacy and immunogenicity between the biosimilar candidate and the rituximab originator product (MabThera).[2] Adverse events related to both products were similar for both medicines.[2]
Sandoz’ biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.
Its biosimilar rituximab candidate was accepted by the EMA for regulatory review in May 2016. Sandoz is seeking approval for the same indications as the reference product with the same presentations which is used to treat autoimmune diseases such as rheumatoid arthritis as well as a number of hematological cancers.
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Sandoz has a leading biosimilar pipeline and plans to make 10 regulatory filings over a three-year period (2015-2017), having already submitted six and had one approved. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
About the Phase I etanercept study
(Annual European Congress of Rheumatology (EULAR 2016) ref: THU0145)
This study was a randomized, two-way crossover trial comparing the PK and safety of Sandoz’ biosimilar etanercept candidate with originator etanercept (Enbrel) in 54 healthy subjects, with a washout period of at least 35 days between administration of the two study drugs.[1] Follow-up was undertaken for four weeks after the final study drug administration.[1]
About the Phase II rituximab study
(Annual European Congress of Rheumatology (EULAR 2016) ref: FRI0222)
This was a prospective, randomized, double blind study in 173 patients with active rheumatoid arthritis not responsive to conventional therapies (disease-modifying antirheumatic drugs or TNF inhibitors).[2] Primary analysis was performed at week 24 with efficacy and PD data collected to week 52, with safety follow-up ending 24 weeks after the last administration of study medication.[2]