BioCentury | Jun 30, 2020
Finance

Qiming-backed Gan & Lee hits ceiling to reach $5.2B market cap in first day on Shanghai

...focus, it has already filed global INDs for other indications. The company markets APIs and biosimilar insulin...
BioCentury | Jun 12, 2020
Regulation

Approval of Biocon, Mylan insulin product could herald cheaper insulin in U.S.

...New Zealand. The partners market Semglee in more than 45 countries. Sandi Wong, Assistant Editors Semglee, Basalog, biosimilar insulin...
BioCentury | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

...expect June FDA decision on insulin biosimilar Following an August complete response letter for its biosimilar insulin...
BioCentury | Nov 26, 2019
Politics & Policy

FDA moves to waive immunogenicity studies for biosimilar insulin

...that the agency should scale back immunogenicity study requirements to speed development of interchangeable or biosimilar insulin...
BioCentury | May 14, 2019
Politics & Policy

Mylan calls for streamlined interchangeable insulin pathway

...for all biologicals.” Christine Simmon, executive director of the Biosimilars Council, emphasized that if a biosimilar insulin...
BioCentury | Apr 2, 2019
Politics & Policy

FDA to hold hearing on new interchangeable insulin policy

...of interchangeable insulin products, some lawmakers and stakeholders have argued FDA's implementation plan will delay biosimilar insulin...
BioCentury | Dec 11, 2018
Politics & Policy

FDA biosimilars policies will bring interchangeable insulin to market

...because it has been difficult to satisfy FDA’s requirements for a generic drug. The first biosimilar insulin...
BioCentury | Jun 8, 2018
Clinical News

Mylan, Biocon get CRL for insulin glargine follow-on

...Mylan N.V. (NASDAQ:MYL), Canonsburg, Pa. Product: Follow-on insulin glargine (MYL-1501D) Business: Endocrine/Metabolic Elizabeth S. Eaton Semglee, Basalog, biosimilar insulin...
BioCentury | Jun 5, 2018
Company News

Mylan, Biocon get CRL for insulin glargine follow-on

...June 4) . Lantus is a long-acting human insulin analog. Elizabeth S. Eaton Basalin, insulin glargine Semglee, Basalog, biosimilar insulin...
BioCentury | Mar 30, 2018
Clinical News

Mylan, Biocon insulin glargine biosimiliar approved in EU and Australia

...India Mylan N.V. (NASDAQ:MYL), Canonsburg, Pa. Product: Semglee biosimilar insulin glargine (Basalog) Business: Endocrine/Metabolic Elizabeth S. Eaton Basalog, biosimilar insulin...
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