Proposed rituximab and etanercept biosimilars recommended for approval in Europe

Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both the biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.

“We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines,” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “Today’s recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios”.

If approved, the Sandoz biosimilar rituximab may be used in all indications of the reference medicine, MabThera^®, which are non-Hodgkin’s lymphoma – follicular lymphoma and diffuse large B-cell lymphoma – chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

If Sandoz’s biosimilar etanercept is approved, it may be used in all indications of the reference medicine, Enbrel^®, which are rheumatoid arthritis, axial spondyloarthritis – (ankylosing spondylitis, non-radiographic axial spondyloarthritis) – plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and paediatric psoriasis.

The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical – including pharmacokinetic/pharmacodynamic – data were generated. The programs demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines.^1–7

• Studies within the biosimilar rituximab development program included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA)⁷ and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL).⁸
• The biosimilar etanercept development program included an innovative Phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY), which included three treatment switches between the reference medicine and biosimilar etanercept.⁴

References

1. European Medicines Agency 2017. The European public assessment reports are published on the European Medicines Agency website (cited 03 March 2017). Available from:  http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar…
2. Visser J et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. BioDrugs. 2013;27:495-507.
3. Da Silva A et al. Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014;55:1609-1617.
4. Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to- severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead of print].
5. von Richter O et al. GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its auto-injector device with pre-filled syringes. Br J Clin Pharmacol. 2016 Oct 27. doi: 10.1111/bcp.13170. [Epub ahead of print]
6. Hofmann HP et al. Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel^®). Exp Opin Biol Ther. 2016;16:1185-95.
7. Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222.
8. Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma ASH annual meeting, 3-6 December 2016, San Diego, USA:1809.