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biosimilar

Showing 15 posts of 70 posts found.

NICE release new guidance on rheumatoid arthritis treatment

June 10, 2021
NICE, biosimilar, rheumatoid arthritis

NICE has today published final draft guidance for the treatment of moderate rheumatoid arthritis in patients who have not responded …

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celltrion1

Celltrion’s Humira biosimilar is comparable in treating rheumatoid arthritis

November 4, 2020
Research and Development Humira, biosimilar, celltrion, 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 …

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shutterstock_36423250

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

August 18, 2020
Manufacturing and Production, Sales and Marketing China, Henlius, Herceptin, Roche, biosimilar

China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s …

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Pfizer scores EU approval for MabThera biosimilar Ruxience

April 6, 2020
Sales and Marketing MabThera, Pfizer, Ruxience, biosimilar

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

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

February 4, 2020
Manufacturing and Production, Sales and Marketing MabThera, Pfizer, Ruxience, biosimilar, pharma

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has revealed that it has awarded a positive opinion for …

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

November 18, 2019
Sales and Marketing Abrilada, FDA, Humira, Pfizer, biosimilar, pharma

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

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celltrion1

Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation

September 24, 2019
Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …

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sandoz

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

September 3, 2019
Manufacturing and Production, Sales and Marketing Polpharma, Sandoz, biosimilar, multiple sclerosis, pharma

Sandoz has revealed that it has sealed a deal with Polpharma Biologics to commercialise the latter’s proposed biosimilar version of …

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FDA approves Pfizer’s Herceptin biosimilar Trazimera

March 12, 2019
Manufacturing and Production, Sales and Marketing Humira, Pfizer, Trazimera, biosimilar, pharma

Patients in the US will now be able to access another biosimilar version of Herceptin (trastuzumab) with the FDA approval …

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samsung

FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant

January 22, 2019
Manufacturing and Production, Sales and Marketing FDA, Herceptin, Samsung Bioepis, biosimilar, pharma

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), …

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amgen_flag

Amgen launches first biosimilar of best-selling Humira in Europe

October 16, 2018
Manufacturing and Production, Sales and Marketing Amgen, Amgevita, Humira, biosimilar, pharma

Amgen has announced the launch of a proprietary biosimilar version of Abbvie’s best-selling drug Humira (adalimumab) across all European markets, …

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merckwindow_web

MSD and Samsung Bioepis terminate development of Lantus biosimilar for diabetes

October 15, 2018
Research and Development, Sales and Marketing Lantus, MSD, Samsung Bioepis, Sanofi, biosimilar, diabetes, pharma

MSD has reportedly terminated a previous agreement with Samsung Bioepis which would have seen them collaborate on a biosimilar version …

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Sackler-owned Mundipharma acquires biosimilar firm Cinfa Biotech

October 10, 2018
Research and Development Mundipharma, biosimilar, cinfa biotech, sackler

In a bid to strengthen their biosimilar portfolio, the Cambridge based pain management company Mundipharma has acquired biosimilar development firm …

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humira_abbott__4

EU approval for Mylan and Fujifilm’s Humira biosimilar

September 21, 2018
Medical Communications, Sales and Marketing EU, Europe, Humira, Mylan, biosimilar, pharma

The European Commission has approved its fifth biosimilar of the world’s best-selling drug, Abbvie’s Humira (adalimumab), granting marketing authorisation to …

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Pfizer notches two EU approvals, including Herceptin biosimilar

August 1, 2018
Research and Development, Sales and Marketing Cancer, EMA, EU, Genetech, Herceptin, Pfizer, Trazimera, Xeljanz, biosimilar, breast cancer, pharma

Pfizer is patting itself on the back after securing two new approvals in Europe within 24 hours: Xeljanz (tofacitinib citrate) …

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