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20 results
8:15 AM, Sep 01, 2017  |  BC Week In Review | Clinical News  |  Regulatory

EC approves Bioepis' Humira biosimilar

biosimilars. Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass.  Samsung BioLogics Co. Ltd. (KOSDAQ:207940), Seoul, South Korea  Product: Biosimilar adalimumab
12:07 PM, Jul 03, 2017  |  BC Week In Review | Clinical News  |  Regulatory

CHMP recommends Imraldi biosimilar adalimumab

EMA’s CHMP recommended approval of Imraldi biosimilar adalimumab (SB5) from Samsung Bioepis Co. Ltd. to treat psoriasis …
Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.  Samsung Group , Seoul, South Korea  Product: Imraldi biosimilar adalimumab
12:51 PM, Jun 09, 2017  |  BC Week In Review | Clinical News  |  Regulatory

EMA accepts MAA for Humira biosimilar from Fujifilm, Kyowa

Fujifilm Holdings Corp. (Tokyo:4901), Tokyo, Japan  Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151), Tokyo, Japan  Product: Biosimilar adalimumab
10:14 PM, Mar 30, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

CHS-1420: Ph I CHS-1420-03 data

12 (see BioCentury, Aug. 15, 2016 ). Coherus BioSciences Inc. (NASDAQ:CHRS), Redwood City, Calif.  Product: Biosimilar adalimumab
5:48 PM, Mar 29, 2017  |  BC Week In Review | Clinical News  |  Regulatory

Amgevita, Solymbic regulatory update

alpha . Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif.  Product: Amjevita adalimumab-atto (Amgevita, Solymbic - EU) biosimilar adalimumab
6:12 PM, Feb 22, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

PF-06410293: Ph III REFLECTIONS B538-02 data

12. AbbVie Inc. (NYSE:ABBV; Chicago Ill.) markets Humira. Pfizer Inc. (NYSE:PFE), New York, N.Y.  Product: Biosimilar adalimumab
4:01 PM, Feb 02, 2017  |  BC Week In Review | Clinical News  |  Regulatory

Amgevita, Solymbic regulatory update

tumor necrosis factor (TNF) alpha . Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif.  Product: Amgevita, Solymbic biosimilar adalimumab
2:44 PM, Jan 20, 2017  |  BC Week In Review | Clinical News  |  Regulatory

BI 695501 regulatory update

BI 695501 or when it expects regulatory decisions. Boehringer Ingelheim GmbH , Ingelheim, Germany  Product: Biosimilar adalimumab
1:33 PM, Jan 20, 2017  |  BC Week In Review | Clinical News  |  Clinical Results

BI 695501: Ph III data

BI 695501 or when it expects regulatory decisions. Boehringer Ingelheim GmbH , Ingelheim, Germany  Product: Biosimilar adalimumab
8:44 AM, Dec 02, 2016  |  BC Week In Review | Clinical News  |  Clinical Results

M923: Ph III data

Inc. in June (see BioCentury, Oct. 3 ). Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), Cambridge, Mass.  Product: Biosimilar adalimumab

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