FiercePharmaAsia—Samsung’s Remicade biosim, Otsuka and Akebia’s $865M deal, experts’ view on China policy

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Samsung won FDA approval for its Remicade biosimilar, triggering an interesting rivalry that also involves Johnson & Johnson, Merck & Co. and Pfizer.

Welcome to this week’s FiercePharmaAsia report, which includes stories about an interesting competition around Remicade and its biosimilars, Otsuka's expanded anemia deal with Akebia, Big Pharmas' and analysts' insights on China's new foreign drug regulation proposal, and more.

1. Samsung biosim nod sets J&J's Remicade up for tough fight with Merck and Pfizer

Samsung Bioepis won FDA approval for its Remicade substitute, Renflexis, becoming the second biosimilar to threaten that brand in the U.S. The med is already marketed as Flixabi in the EU. The rivalry looks interesting as Merck & Co. has Remicade marketing rights outside the U.S. and rights to Renflexis in the U.S. at the same time. Pfizer has its biosimilar version in both the U.S. and Europe.

2. Akebia, Otsuka pen $865M expansion to anemia pill pact

Otsuka has expanded its anemia pact originally formed late last year with Akebia Therapeutics. The revised deal gives Otsuka the rights to vadadustat in certain regions outside the U.S. in return for $73 million upfront and up to $792 in development funding and milestone payments. It has already paid $125 million and committed to up to $905 million in milestones for the U.S. rights.

3. China’s new foreign drug proposal: Pharmas excited, analysts cautious

China FDA’s new foreign drug registration regulation could be up soon. Major foreign pharma players in China, including Pfizer, AstraZeneca and Sanofi, are excited that the new rule could “significantly speed up the registration process.” But market watchers are more cautious in expressing their optimism, especially in the short term, and want to see “if the implementation details do work out.”

4. Novartis to pay $50M, lose some drug coverage in Korean bribery probe

Korea’s health authorities fined Novartis about $50 million and suspended reimbursement of Exelon and Zometa after the company allegedly bribed doctors to pump up sales. They left the company’s big-selling cancer med Glivec untouched out of concern for patients’ welfare. That followed a small fine and a 3-month suspension on three meds imposed by the country’s food and drug authority.

5. KKR in ‘advanced talks’ to pick up India’s SRL Diagnostics

Private equity giant KKR is in “advanced” discussions to acquire a stake in New Delhi-based SRL Diagnostics, valuing SRL at about 50 billion rupees ($775 million), per a report by Bloomberg. SRL, which bills itself as the largest diagnostics company in India, is being spun off from Fortis Healthcare, one of India’s largest private hospital chains.

6. Daiichi Sankyo to beef up ADC production with $135M investment in Japan

Japan’s Daiichi Sankyo, which has been in cost-cutting mode for several years, says it will invest about $135 million to build and refurbish manufacturing lines at three of the company’s plants in Japan to produce antibody-drug conjugates as its looks to targeted cancer meds to help fuel its future. The expansion will more than triple the company’s ADC capacity by 2021.

7. FDA warning letter says Teva China plant has more work to do on API issues

For nearly two years, Teva struggled with impurity issues for an API manufactured at a plant in China, problems that affected about 20% of the product’s production. While the drugmaker has been working for months to get on top of the problems, the FDA said in a warning letter to the generics giant that it has yet to be convinced Teva has solved all problems.

8. Serum Institute picks up Czech vaccine factory in €72M deal

Serum Institute of India has struck a deal to buy Nanotherapeutics and pick up a defunct Czech outfit which used to manufacture Baxter flu vaccines for €72 million. The vaccinemaker plans to invest another €30 million to €40 million to get the plant up and running, with the goal of becoming the largest injectable polio vaccine maker in the world by 2020.

9. Sun Pharma's FDA quagmire gets stickier with citation of Dadra plant

It’s data integrity again for Sun Pharma. The Indian drugmaker has had another setback in its manufacturing for the U.S. market, with the FDA laying out 11 observations for a solid dose formulation plant in Dadra. Other issues include not getting to the root cause of failed batches and the plant’s quality-control unit not having the authority to review manufacturing records.

10. FDA warning scorches Divi's Labs for refusing to cough up API records

For another Indian manufacturer, Divi’s Labs, the issue is obstruction of inspection. The FDA, which banned APIs coming from a plant of its in India last month, has followed that up with a warning letter that savages the facility for refusing to give inspectors records they needed to evaluate whether its drugs were adulterated.