Pharminent

Boehringer’s Humira biosimilar wins US green light

US regulators have approved Boehringer Ingelheim’s Cyltezo, a biosimilar to AbbVie’s Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases. http://www.pharmatimes.com/news/boehringers_humira_biosimilar_wins_us_green_light_1203707

Filed under: Biosimilar

Second US infliximab biosimilar launched at 35% discount to J&J’s Remicade

Merck & Co. will challenge both reference drugmaker J&J and fellow biosimilar developer Pfizer through its version of Remicade, Renflexis. http://www.biopharma-reporter.com/Markets-Regulations/Merck-Co.-launches-US-Remicade-biosimilar-at-35-discount

Filed under: Biosimilar

Biosimilar immunogenicity studies produce no surprises

MADRID (FRONTLINE MEDICAL NEWS) – Two biosimilar tumor necrosis factor inhibitor (TNFi) products are no more immunogenic than their reference biologic counterparts in patients with rheumatoid arthritis (RA), according to the results of two studies presented at the European Congress of Rheumatology. Results of one study, which involved 544 RA patients, showed 33.1% treated with […] http://www.pm360online.com/biosimilar-immunogenicity-studies-produce-no-surprises/

Filed under: Biosimilar

Sandoz secures fourth biosimilar approval in Europe with Rixathon

Sandoz, a division of Swiss firm Novartis, has announced that the European Commission has approved its biosimilar Rixathon for the same indications as its reference product rituximab.
These indications include the treatment of blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, and immunological disorders including rheumatoid arthritis, granulomatosis with polgyangitis and microscopic polyangitis.
read more http://www.pharmafile.com/news/514404/sandoz-secures-fourth-biosimilar-approval-europe-rixathon

Filed under: Biosimilar

New EMA guidelines on biosimilar medicines

https://www.europeanpharmaceuticalreview.com/51788/news/industry-news/new-guide-biosimilar-medicines/

Filed under: Biosimilar

Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar

Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar – Positive opinion based on a clinical development program involving over 1,000 people with type 1 or type 2 diabetes – .. http://www.euroinvestor.com/news/2017/05/19/sanofi-receives-chmp-recommendation-for-approval-of-insulin-lispro-biosimilar/13603431

Filed under: Biosimilar

Sandoz Proposed Biosimilars Recommended for Approval in Europe

NewsThe CHMP recommendations were based on two comprehensive development programs.Topics: Drug Pipeline https://www.dddmag.com/news/2017/05/sandoz-proposed-biosimilars-recommended-approval-europe

Filed under: Biosimilar

US green light for Remicade biosimilar

US regulators have approved Renflexis, a biosimilar referencing Johnson & Johnson’s tumour necrosis factor (TNF) blocker Remicade (infliximab), across all eligible indications. http://www.pharmatimes.com/news/us_green_light_for_remicade_biosimilar_1191717

Filed under: Biosimilar

Amgen wins European approval for Humira biosimilar Amgevita

European Commission approves the first version of AbbVie’s blockbuster http://www.pmlive.com/pharma_news/amgen_wins_european_approval_for_humira_biosimilar_amgevita_1190009

Filed under: Biosimilar

Global trade bodies issue guidance on biosimilar switching

https://www.europeanpharmaceuticalreview.com/49254/news/industry-news/global-trade-bodies-issue-guidance-biosimilar-switching/

Filed under: Biosimilar

Mundipharma to launch Mabthera biosimilar in EU markets

Mundipharma is gearing up to launch biosimilar Truxima in seven European markets for the treatment of certain cancers and inflammatory conditions, after Celltrion bagged a regulatory approval for the drug. http://www.pharmatimes.com/news/mundipharma_to_launch_mabthera_biosimilar_in_eu_markets_1187412

Filed under: Biosimilar

US FDA issues final guidance on biosimilarity data use

The US FDA has published final guidance on the development and use of clinical pharmacology data for drugmakers to demonstrate biosimilarity. http://www.biopharma-reporter.com/Markets-Regulations/US-FDA-issues-final-guidance-on-biosimilarity-data-use

Filed under: Biosimilar

Celltrion sets sights on 2017 for EU and US rituximab biosimilar success

Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea. http://www.biopharma-reporter.com/Markets-Regulations/Celltrion-sets-sights-on-2017-for-EU-US-Rituxan-biosimilar-success

Filed under: Biosimilar

Pfizer plans to launch REMICADE biosimilar in US in November

Pfizer said it will begin shipping INFLECTRA (infliximab-dyyb)for injection, a biosimilar of REMICADE (infliximab) to wholesalers in the US in late November 2016. http://drugdelivery.pharmaceutical-business-review.com/news/pfizer-plans-to-launch-remicade-biosimilar-in-november-5034798

Filed under: Biosimilar

Teva, Celltrion Announce Exclusive Biosimilar Commercial Partnership

NewsBoth CT-P10 and CT-P6 are currently in late-stage Phase III development and their primary endpoints have been successfully achieved.Topics: Life Sciences http://www.dddmag.com/news/2016/10/teva-celltrion-announce-exclusive-biosimilar-commercial-partnership

Filed under: Biosimilar

Momenta, Coherus BioSciences Are Both Good Options in the Biosimilar Space

https://www.thestreet.com/story/13841260/1/momenta-coherus-biosciences-are-both-good-options-in-the-biosimilar-space.html

Filed under: Biosimilar

Shire gives up on Momenta-partnered Humira biosimilar

Will fund programme
for another 12 months while divesting ongoing activities to Momenta http://www.pmlive.com/pharma_news/shire_gives_up_on_momenta-partnered_humira_biosimilar_1147422

Filed under: Biosimilar

FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

Filed under: Biosimilar

UK launch for Biogen’s biosimilar infliximab

Biogen has launched Flixabi – a biosimilar of Johnson & Johnson’s blockbuster infliximab – across the UK for use in a range of chronic inflammatory conditions. http://www.pharmatimes.com/news/uk_launch_for_biogens_biosimilar_infliximab_1124051

Filed under: Biosimilar

Novartis wins US approval for Enbrel biosimilar

Erelzi is only the third biosimilar drug approved in the U.S., following copies of Amgen’s Neupogen and Johnson & Johnson’s Remicade.  http://www.biopharmadive.com/news/novartis-biosimilar-enbrel-amgen-fda/425434/

Filed under: Biosimilar

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