FiercePharmaAsia—Lantus biosimilar, Takeda’s Zika vaccine, Celltrion warning letter

The FDA sent a warning letter to Japan’s Daito Kasei Kogyo. (Daito Kasei Kogyo)

Welcome to this week's FiercePharmaAsia report, which includes stories about Mylan and Biocon's Lantus biosimilar, Takeda's Zika vaccine candidate, Celltrion's plant that produces Pfizer's biosimilars, and more.

1. Mylan and Biocon win CHMP nod for Lantus biosimilar after getting beyond plant issues

Mylan and Biocon have won an EU recommendation for approval of Semglee, a biosimilar to Sanofi’s blockbuster insulin Lantus. The review was previously delayed after EU investigators found issues with the Biocon plant in India during an inspection for the pair’s Herceptin and Neulasta copycats and the pen assembly for Semglee.

2. Takeda’s Zika vaccine candidate wins FDA fast-track status

Even after the WHO stopped classifying Zika as an “emergency” in late 2016, Takeda pressed ahead with its program. This week it won the FDA's fast-track designation. The project is currently in phase 1 in the U.S. and has a government funding promise worth up to $312 million all the way through a potential FDA approval.

3. FDA spanks Celltrion South Korean biosimilars plant with warning letter

The FDA Form 483 Celltrion got last fall for the plant where it produces Pfizer’s biosimilars has now been elevated to a warning letter. But the drugmaker said the action against one of its Incheon plants doesn’t affect its production of Inflectra, a Remicade biosimilar it produces with Pfizer.

4. Philippine health authority demands full Dengvaxia refund from Sanofi

The Philippine's government is now demanding Sanofi refund some $39 million for used Dengvaxia doses, just days after Sanofi had agreed to refund for unused doses. Health Secretary Francisco Duque III said “the purported protection wasn’t felt,” and attributed the decision to the label change.

5. Former Sanofi and BMS plants in EU reclaimed by Asian drugmakers

Accord Healthcare, a unit of India’s Intas Pharmaceuticals, has reopened a solid-dose plant in the U.K. that it picked up in 2015 after Sanofi closed the facility. South Korea’s SK Biotek has started operations at an API plant in Ireland that it bought last year from Bristol-Myers Squibb, while holding a contract to produce some products for BMS.

6. Tyto bags $25M to grow U.S. telehealth sales, target China

Telehealth startup Tyto Care has raised $25 million to grow U.S. sales of its FDA-approved digital stethoscope, the core piece of three telehealth packages for consumers and healthcare organizations. With the series B, the Israeli company also has its eyes on China, including a relationship with Chinese insurance giant Ping An, which led the round.

7. Bharat Biotech's Rotavac, a discounted option to GSK and Merck vaccines, picks up WHO prequalification

India's Bharat Biotech has won WHO prequalification for its rotavirus vaccine Rotavac. At $3 per course, the vaccine is cheaper than Glaxo's Rotarix and Merck's RotaTeq, which cost $4.02 and $9.60 per course. The shot is already available in India, and the company said it has the manufacturing capacity to meet global demands.

8. FDA warns API maker Daito Kasei Kogyo, bans some products

A warning letter was sent to Japan’s Daito Kasei Kogyo, and the FDA has banned products from the company’s Okayama plant to the U.S. According to the FDA, the facility wasn’t meeting even minimal standards. For example, it didn’t test ingredients for identity and assay before releasing the drugs.