Ask a CFIUS Expert: Is Crypto Spying on Us?
Hot Topics in International Trade-Braumiller Law Group-FDI Into Mexico from China
4 Key Takeaways | Solar Industry & Chinese Tariff Update
10 Key Trade Developments: Trade Remedy Cases
Episode 309 -- Alex Cotoia on Compliance with the Uyghur Forced Labor Prevention Act
10 Key Trade Developments: China
Noteworthy Points in the Rules for the Implementation of China's Patent Law 2023
JONES DAY TALKS®: Corporate Compliance in Asia: Managing Rapid Regulatory Change and Ambiguity
Hot Topics in International Trade. Braumiller Law Group Partner & Founder Adrienne Braumiller joins Vp of Marketing Bob Brewer for an Update on Forced Labor
Episode 292 -- 3M's $6.5 Million FCPA Settlement with the SEC
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Third Party Observation in Patent Prosecution in China
The Grace Period for Novelty in Chinese Patent Law
One Month to a More Effective Compliance Program with Boards – Day 14 - Boards and Doing Business in China
Episode 276 -- Review of Phillips and Franks Int'l SEC FCPA Settlements
Sanction and the Increasing Complexity of Trade Compliance
Braumiller Law Group Help With China Imports
Coming Conflict with China: Part 5 - Good Compliance Is Good Business
JONES DAY PRESENTS®: Taiwan's Enhanced Trade Secret Restrictions and Stricter Penalties
JONES DAY PRESENTS: The Challenges of Defending Trade Secrets in China
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more
On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal...more
On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women at high risk of...more
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab). BAT1806 is approved for the treatment of rheumatoid...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of...more
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products...more
On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar...more
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab),...more
Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a...more
Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and...more
Last week, BeiGene and Bio-Thera Solutions announced that the companies had entered into a license, distribution, and supply agreement for BAT1706, Biothera’s Avastin® (bevacizumab) biosimilar, in China. According to the...more
Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved HLX14, a denosumab biosimilar. Denosumab is a recombinant humanized anti-RANKL monoclonal...more
Shanghai Henlius biosimilar antibody developments - On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products...more
The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....more
Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and...more
Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the...more
The past few weeks have seen the following biosimilar developments in China: ..On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been...more
On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar...more
Below are some highlights of recent news in biosimilar development: Earlier this week, Mylan and Revance Therapeutics, who are collaborating in developing a biosimilar of BOTOX (onabotulinumtoxinA), reported on their...more
Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more
Guangzhou-based biopharmaceutical company Bio-Thera Solutions recently announced that the China National Drug Administration has accepted for review the BLA for BAT1406, a proposed Humira® (adalimumab) biosimilar. Bio-Thera...more
Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly...more