Tagged as: Trastuzumab

Biocon Biologics Expands Access to Biosimilars In Over 30 Countries In Africa and Asia

Biocon Biologics, a subsidiary of Biocon, announced today that it has signed an agreement with Clinton Health Access Initiative (CHAI) to develop advanced cancer therapies for patients in 25 countries in Africa and 5 countries in Asia as part of the Cancer Access Partnership (CAP). According to the announcement, Biocon Biologics aims…

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Q4 2020 and Full Year Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…

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Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

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Biosimilars Report On Biologics and Biosimilars Market in the United States Released This Week

This week, IQVIA released an independent report on its research into the current state of the biologics market in the United States. IQVIA, formerly Quintiles and IMS Health, Inc., is a contract research organization serving the combined industries of health information technology and clinical research. In an overview of the…

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Lotus and CKD Announce Biosimilar Collaboration

On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure.  According to Lotus’ press…

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Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…

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Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status

Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards.  WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders.  Herzuma has been commercially available in Europe since May 2018,…

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Genentech v. JHL case schedule extended

As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products.  However, the case continued against the four former Genentech employees as individual defendants, although…

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Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

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