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biosimilar

Celltrion's Humira biosimilar is comparable in treating rheumatoid arthritis

Celltrion has revealed new Phase 3 data demonstrating that its high concentration (100mg/mL) and citrate-free biosimilar CT-P17 proved comparable to its reference product, AbbVie’s best-selling Humira (adalimumab), in the treatment of rheumatoid arthritis (RA).

Revealed at the American College of Rheumatology (ACR) Convergence 2020, the findings compared Celltrion’s product to Humira in terms of efficacy, safety and pharmacokinetics. In the trial, 648 moderate-to-severe RA patients were randomly given either Celltrion or AbbVie’s drug fortnightly for 24 weeks.

China approves its first biosimilar of Roche's Herceptin in HER2+ cancers

China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s Herceptin (trastuzumab) known as HLX02 for the treatment of HER2-mutated cancers.

Specifically, the therapy will now be available for use in the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, just like its reference product.

Pfizer scores EU approval for MabThera biosimilar Ruxience

The European Commission has moved to authorise Ruxience, Pfizer’s biosimilar version of MabThera (rituximab).  The decision marks the seventh biosimilar approval for Pfizer in Europe.

The approval authorises the drug for the same indications as its reference product, including  the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Europe's CHMP recommends Pfizer's biosimilar of Roche's MabThera

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has revealed that it has awarded a positive opinion for Pfizer’s Ruxience, a biosimilar version of Roche’s MabThera (rituximab).

Upon review of submitted data, the CHMP found no clinically meaningful differences between the two products, confirming Ruxience’s biosimilarity to MabThera.

Pfizer's Humira biosimilar secures FDA approval, due to launch in 2023

Pfizer has confirmed the FDA approval of Abrilada (adalimumab-afzb),  its biosimilar version of AbbVie’s Humira, the world’s best-selling drug,  

Pfizer’s therapy is now authorised for use in all approved indications of its reference product, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Celltrion's subcutaneous infliximab biosimilar secures CHMP recommendation

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous version of Remsima (biosimilar infliximab), in the treatment of rheumatoid arthritis, it has emerged.

As a subcutaneous formulation, the therapy “has the potential to enhance treatment options…by providing high consistency in drug exposure and a convenient method of administration,” according to the manufacturer.

Sandoz acquires global commercialisation rights to Polpharma's multiple sclerosis biosimilar

Sandoz has revealed that it has sealed a deal with Polpharma Biologics to commercialise the latter’s proposed biosimilar version of natalizumab around the world. The biosimilar product is currently undergoing clinical testing at Phase 3 in the treatment of relapsing-remitting multiple sclerosis (RRMS). 

Under the agreement, Polpharma will handle development, manufacturing and supply responsibilities. Following approval from regulatory agencies, Sandoz will handle marketing and distribution duties across all markets exclusively.

FDA approves Pfizer's Herceptin biosimilar Trazimera

Patients in the US will now be able to access another biosimilar version of Herceptin (trastuzumab) with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Data supplied with the application supported the similarity of Trazimera to its reference product, including clinical equivalence and no clinically meaningful differences between them.

FDA approves third Herceptin biosimilar with Samsung Bioepis' Ontruzant

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), in the same indications as its reference product.

This includes three cancer indications: as an adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

Amgen launches first biosimilar of best-selling Humira in Europe

Amgen has announced the launch of a proprietary biosimilar version of Abbvie's best-selling drug Humira (adalimumab) across all European markets, beginning 16 October.

Amgevita, as the biosimilar is known, is the first such version of the world’s best-selling drug to secure approval from the European Commission, and as such is authorised for use in all the indications of its reference product, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); moderate-to-severe chronic plaque psoriasis; moderate-to-severe Crohn's dise

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