Several companies have advanced biosimilars for blockbluster biologics. The European Commission has approved Sandoz’s Erelzi (biosimilar etanercept), a biosimilar of Amgen’s Enbrel. An advisory committee of the European Medicines Agency has adopted a positive opinion for Samsung Bioepis’ Imraldi, a biosimilar of AbbVie’s Humira, and the FDA has accepted for review a proposed biosimilar to Roche’s Rituxan/MabThera from Teva and Celltrion.

Sandoz Receives EC Approval for Biosimilar of Amgen’s Enbrel
The European Commission (EC) has approved from Sandoz, the generics arm of Novartis, Erelzi (biosimilar etanercept), a biosimilar of Amgen’s Enbrel (etanercept).  Erelzi is approved for use in all indications of the reference medicine, Enbrel. Amgen’s Enbrel had global 2016 sales of $5.97 billion.

Erelzi is approved for rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis as well as juvenile idiopathic arthritis and pediatric plaque psoriasis. Erelzi is available in a prefilled syringe and an auto-injector pen, SensoReady.

The US Food and Drug Administration approved Erelzi in August 2016.

Earlier this month, Sandoz received EC approval for Rixathon, a biosimilar referencing Roche’s MabThera, a drug to treat cancer and autoimmune diseases, in all indications. MabThera/Rituxan is Roche’s top-selling drug with 2016 sales of CHF 7.3 billion ($7.48 billion).

Source: Sandoz

EMA Advisory Committee Recommends Approval of Samsung Bioepis’ Biosimilar to AbbVie’s Humira
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Samsung Bioepis’ Imraldi, a biosimilar of AbbVie’s Humira (adalimumab), an autoimmune drug. Humira is AbbVie’s top-selling drug with sales of $16.1 billion. Samsung Bioepis is an Incheon, South Korea-headquartered biopharmaceutical company that is a joint venture between Samsung BioLogics and Biogen.

Imraldi was approved for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis,and uveitis.

The CHMP’s positive opinion will now be referred to the European Commission, which will review and decide on the grant of a marketing authorization for Imraldi. If such authorization is granted, Imraldi will be commercialized in the European Union by Biogen.

In April 2017, Samsung Bioepis also received approval by the US Food and Drug Administration for Renflexis (infliximab-abda), a biosimilar referencing Johnson & Johnson’s (J&J) blockbuster drug, Remicade (infliximab) across all indications. Remicade is the top-selling drug in J&J’s pharmaceuticals division with 2016 sales of $6.97 billion.

Samsung Bioepis is developing several other biosimilars, including a biosimilar to Amgen’s Enbrel (etanercept); a biosimilar to Sanofi’s Lantus (insulin glargine); and a biosimilar to Roche’s Herceptin (trastuzumab).

Source: Samsung Bioepis  and Biogen

FDA Accepts Celltrion’s and Teva’s Biologics License Application for Rituxan Biosimilars
The US Food and Drug Administration (FDA) has accepted for review the biologics license application (BLA) from Celltrion, an Incheon, Korea-based biopharmaceutical company, and Teva Pharmaceutical Industries for CT-P10, a proposed biosimilar to Roche’s blockbuster drug Rituxan/MabThera (rituximab), a drug to treat certain cancers and autoimmune diseases. MabThera/Rituxan is Roche’s top-selling drug with 2016 sales of CHF 7.3 billion ($7.48 billion).

The drug is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Celltrion and Teva entered into an exclusive partnership to commercialize CT-P10 and CT-P6, a biosimilar to Roche’s Herceptin (trastuzumab), in the US and Canada in October 2016. As part of the agreement, Teva is responsible for all commercial activities in the US and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.

The BLA for CT-P10 has been accepted for standard review filing with the FDA, with FDA regulatory action expected during the first quarter of 2018. CT-P10 was approved by the European Commission in February 2017 and has been launched in the UK, Germany, the Netherlands, Spain, and the Republic of Korea.

Earlier this month, the European Commission approved from Sandoz, the generics arm of Novartis, Rixathon, a biosimilar referencing Roche’s Rituxan/MabThera

Source: Teva Pharmaceutical