FiercePharmaAsia—Novartis’ kickback allegation, Samsung’s Humira biosim, Takeda’s Shire plan

Novartis is facing allegations in China that it laundered doctor kickbacks through fake academic events, Samsung Bioepis has pushed back the U.S. launch of its Humira biosimilar by years in a settlement with AbbVie, Takeda is seeking billions of dollars in loans to finance a $40 billion-plus Shire bid, and more.

1. Novartis, still embroiled in Greek probe, faces kickback allegation in China—again

Novartis, already at the center of a high-profile bribery scandal in Greece, now faces new accusations in China. A self-identified recent employee at its Beijing office accused the Swiss pharma of expensing fake academic events to offer kickbacks to doctors for prescription favors. The company said it was in the middle of an internal investigation.

2. AbbVie's Humira gets biosim reprieve—and Amgen wins copycat advantage—in patent deal with Samsung Bioepis

After inking a similar deal with Amgen last year, AbbVie reached a global patent settlement with Samsung Bioepis that pushes out by several years a Humira biosimilar launch in the U.S. But Samsung partner Biogen can still launch the copycat, dubbed Imraldi, in Europe starting this October.

3. Takeda scouts out lenders to back its $40B-plus Shire bid

Takeda seems determined to get its proposed Shire buyout done. The Japanese drugmaker is gauging creditors’ interest in providing loans to help finance the deal, Reuters reported. Because the bid could reach $40 billion, Takeda is looking for tens of billions of dollars from multiple banks.

4. Celltrion hopeful despite FDA setback on 2 of its biosimilars amid plant issues

Celltrion received two complete response letters from the FDA for its biosimilars of Rituxan and Herceptin, but the South Korean company said it is confident that the issues “will be resolved in a timely manner,” and that it will resubmit soon. Novartis and Amgen also have applications for Rituxan and Herceptin biosimilars, respectively, with the FDA.

5. Trump tariffs threaten to cost medical device industry billions

As part of President Trump’s trade battle against China, the U.S. Trade Representative proposes to slap 25% tariffs on Chinese imports of pacemakers, orthopedic implants and other devices. Estimates of the negative annual impact of the tariffs on the device industry range from RBC Capital Markets’ $1.5 billion to AdvaMed’s $5 billion. 

6. Gene-targeted animal model CRO Biocytogen nets $65M series C, eyes global expansion

Beijing-headquartered Biocytogen, which specializes in gene-editing techniques, immunodeficient and immune checkpoint humanized mouse models, and related services, has closed a $65 million series C. It plans to start a preclinical service operation in Boston and build a large R&D base and model production facility in China.

7. Sanofi executives face more requests for charges in Dengvaxia mess as suspicious deaths mount

Families of four children who died after receiving Sanofi’s controversial dengue shot Dengvaxia in the Philippines are asking prosecutors to consider criminal charges against officials with the government, Sanofi and distributor Zuellig. The local health department has recorded 62 deaths suspected to be caused by Dengvaxia and is tasking experts to investigate.