Biosimilar News

Biocon hopes sales of biosimilars will triple

Biosimilar News — Thu, 23 May 2013 09:00:55 +0000

Biocon is upbeat about its biosimilars. The Indian biopharmaceutical company expects the sales revenue from this segment to treble by FY15. Biocon hopes the patent expiry of eight of the top 10 biotech products by 2018 will boost the Indian generics market. Biosimilars contributed about five per cent of Biocon’s $450 million sales in FY12. The contribution of this segment is expected to grow to over 10 per cent in FY15 when the company is projected to achieve total sales [...]

Amgen, Hospira and Sandoz named among top pharmaceutical companies with greatest biosimilar potential in USA

Biosimilar News — Fri, 17 May 2013 08:45:15 +0000

The IP & Science business of Thomson Reuters, the provider of intelligent information for businesses and professionals, announced the release of a life sciences report, “An Outlook on U.S. Biosimilar Competition,” providing a comprehensive view of the challenges facing companies entering the United States biosimilar drug market and key players predicted to break into this developing pharmaceutical space. While the U.S. continues to take steps toward entering the global biosimilar market, it lags behind other nations in this space. The report compares [...]

Indian biotech lobby against Cipla’s etanercept

Biosimilar News — Tue, 14 May 2013 06:52:05 +0000

A lobby group of biotech drug companies in India has raised concerns about the approval of Cipla’s first biosimilar drug Etanercept, used for the treatment of rheumatic disorders. The Association of Biotechnology Led Enterprises (ABLE) fears that Cipla may not have followed prescribed norms while launching the drug, which is sold under the Etacept brand name in India. In a letter to the drug controller of India, ABLE’s president P Murali has asked the regulator to clarify if Cipla has followed the regulatory requirements that are part of [...]

Zheijang Huahai and Oncobiologics create broad biosimilars partnership

Biosimilar News — Thu, 09 May 2013 06:49:08 +0000

Oncobiologics, Inc. announced yesterday that Zhejiang Huahai Pharmaceutical Co., Ltd and Oncobiologics have signed an alliance agreement for the development, manufacture and commercialization of biosimilar monoclonal antibody products. The scope of the agreement includes exclusive commercialization by Huahai of four biosimilars developed by Oncobiologics and manufactured in China at a Huahai biologics facility for the China market, and will also establish a co-development and commercialization partnership for launching such biosimilars to more than 30 developed countries, including the U.S., E.U., [...]

EMA revised the biosimilars guideline and public consultation is now open

Biosimilar News — Tue, 07 May 2013 07:08:54 +0000

The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product and making an application to the agency. While FDA is still arguing the pathway and States are taking actions to restrict and control biosimilar entry in the US, EMA, the pioneer regulatory body for biosimilars and the watchdog of Europe, again released a guideline to describe the steps and improve the [...]

Hospira highlights its success of biosimilar offering

Biosimilar News — Fri, 03 May 2013 07:08:16 +0000

Hospira, Inc. announced an important milestone, commemorating five years of providing biosimilars to the European market and delivery of more than five million doses of high-quality biosimilar medicines at a lower cost to patients in Europe and Australia. Biosimilars were an important industry topic at the BIO International Convention in Chicago last week, with multiple sessions devoted to topics such as biosimilar regulatory approval, manufacturing and market formation. “Bringing biosimilars to the United States is the next major step toward reducing costs for the U.S. healthcare system,” said Thomas Moore, [...]

Amgen welcomes European Commission report on EU biosimilars uptake

Biosimilar News — Thu, 02 May 2013 07:40:18 +0000

Amgen, a biotechnology company developing both innovative biologic and biosimilar medicines, welcomes a new report from the European Commission detailing Europe’s strong regulatory and commercial foundation for biosimilars in the healthcare marketplace. The report shows that biosimilars are helping improve competition and thus may be increasing access to biologic medicines for patients. The science-led regulatory framework in the European Union (EU) has established confidence in biosimilars which has allowed for these therapeutic alternatives to successfully enter into clinical practice. As [...]

LabEx MAbImprove industrial workshops of antibody biosimilars

Biosimilar News — Tue, 30 Apr 2013 08:29:28 +0000

The annual “LabEx MAbImprove industrial workshops” are primarily intended to provide scientists involved in research on therapeutic antibodies, a comprehensive view about topics of interest for the pharmaceutical industry. They are organised by the “LabEx MAbImprove industrial committee”, in partnership with ARITT, the regional agency for innovation and technology transfer which operates inthe French Région Centre, the 1st French region for pharmaceutical production. The one day event will be held in Tours, France, in 28th of May, 2013 and the website of the event [...]

Libbs and mAbxience sign biosimilar agreement in Brazil

Biosimilar News — Tue, 30 Apr 2013 05:28:04 +0000

Libbs Farmacêutica and mAbxience, the biotechnology company of Chemo Group, signed in Brasilia a licensing and technology transfer agreement for several biosimilar monoclonal antibodies developed by mAbxience. Libbs will invest US$ 100 million in the construction of a manufacturing site in Sao Paulo, expected to be ready by 2016, which will produce the biological compounds. The agreement was signed in Brasilia by Hugo Sigman, Founder of Chemo Group, and Alvaro Athayde, vice-president of Operations and Management at Libbs. In attendance [...]

BioOutsource opens new facility in Cambridge, Massachusetts

Biosimilar News — Mon, 29 Apr 2013 09:54:44 +0000

BioOutsource Ltd., a global player in the biological analysis of biosimilar molecules for the biopharmaceutical industry, last week announced the opening of a new facility in Cambridge, Massachusetts, the company’s first in the United States. The company plans to draw on its unparalleled depth of experience in providing biosimilar characterization assays to its European customers, in providing similar services throughout North America. The announcement was made at the 2013 BIO International Convention, “the Global Event for Biotechnology,” in Chicago, Illinois. [...]