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Last updated on April 16, 2014 at 17:13 EDT

Latest Biosimilar Stories

2014-01-22 12:27:07

DUBLIN, Jan. 22, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Allergan, Inc.'s Restasis(®) (cyclosporine ophthalmic emulsion) 0.05% product. Actavis' ANDA was submitted prior to the issuance of FDA guidance related to approval of generic versions of Restasis(®)...

2014-01-17 20:22:00

DUBLIN, Jan. 17, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the United States District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals, Inc. and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin(®) Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate...

2014-01-15 23:22:58

Xtalks presents an exciting live webinar on Thursday, January 30, 2014 at 11:00am EST (4pm GMT). Join keynote speaker Joerg Bluemel, Director of Toxicology within Biologics Safety Assessment / Translational Sciences at MedIummune for a one-hour discussion on nonclinical and clinical Safety Assessment of Biosimilars. Toronto, Canada (PRWEB) January 15, 2014 This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars....

2014-01-09 23:20:23

The Biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. (PRWEB) January 09, 2014 The “Biosimilars Market Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018”, provides a detailed overview of the major...

2014-01-08 20:21:24

Ask Agency to require that biosimilars bear distinguishable names to enhance patient safety WASHINGTON, Jan. 8, 2014 /PRNewswire-USNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. The Petition states...

2014-01-08 16:26:48

DUBLIN, Jan. 8, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis(®). Actavis intends to launch the product immediately. As a "first applicant" to submit a substantially complete ANDA, Actavis is eligible for 180 days of...

2014-01-08 08:27:23

- JHL Biotech to develop and commercialize BL-9020 in China and additional Southeast Asia countries - JERUSALEM and HSINCHU, Taiwan, Jan. 8, 2014 /PRNewswire/ -- BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, and JHL Biotech, a biopharmaceutical company that develops, manufactures, and commercializes biologic medicines, announced today that they have entered into...

2014-01-07 08:32:32

REDWOOD CITY, Calif., Jan 7, 2014 /PRNewswire/ -- Denny Lanfear, President and CEO of Coherus Biosciences, will present at the J.P. Morgan 32(nd) Annual Healthcare Conference on Wednesday, January 15 at the Westin St. Francis in San Francisco, CA., beginning at 4:30pm Pacific Standard Time. (Logo: http://photos.prnewswire.com/prnh/20120507/SF01448LOGO) "Coherus' upcoming presentation at the conference marks an important milestone for our Company. This event will introduce...

2013-12-24 08:24:01

DUBLIN, Dec. 24, 2013 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the Company's subsidiary has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. The Company stated that it intends to work closely with the FDA to address the items raised in the complete response...

2013-12-18 08:29:09

In Brazil, Biosimilars from PDPs (Productive Development Partnerships) Will Have Significant Market Advantages, According to a New Report from Decision Resources BURLINGTON, Mass., Dec. 18, 2013 /PRNewswire/-- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that biosimilars will be quickly acquired and used in public health institutions in Brazil and Mexico in the treatment of patients with rheumatoid...