Merck ditches biosimilar Lantus, but will that ease the path for Mylan’s rival insulin product?

Jumping into the multibillion-dollar market for biosimilar insulin products seemed like a no-brainer for Merck & Co., which is one of the world’s leaders in diabetes.

But the company’s Lantus biosim partnership with Korea’s Samsung Bioepis has faced its share of challenges, not the least of which is a patent fight that has stymied its launch despite a tentative FDA approval last summer

Now Merck is ditching the biosimilar Lantus market altogether and shelling out cash to Samsung Bioepis for its costs, too. That leaves Mylan and its partner Biocon as the only major biosimilar players in a strong position to challenge Eli Lilly and Boehringer Ingelheim’s biosim Basaglar—and Sanofi’s Lantus brand itself, when its last patents expire in 2020.


Merck continues to work with Samsung Bioepis on other biosimilars in oncology and immunology, according to the statement. “We believe that biosimilars can present significant opportunities for cost savings through competition and improved patient access to therapies,” the company said. (See more details on FiercePharma)


Big pharma’s off-patent drugs lose out in China’s new price-cutting scheme

In a Battle of Waterloo-style defeat, off-patent drugs from big pharma firms lost major markets in China as the government adopted a novel procurement scheme to slash generic drug costs. But after steep price cuts, local firms aren’t considered winners, either. In the end, only AstraZeneca’s EGFR inhibitor Iressa and Bristol-Myers Squibb’s heart drug Monopril won their fights against local copycats.

Among the 31 drugs China’s newly formed health insurance watchdog listed for procurement in a pilot program, multinational pharmas participated in bidding to supply almost all of them, but landed only two contracts, according to multiple local reports of preliminary tender results. (See more details on FiercePharma)

Chinese heparin maker banned by EMA over contamination risks

World regulators are cautious about crude heparin after China-made APIs were responsible for dozens of deaths in the U.S. more than a decade ago. Now, European regulators are banning heparin from a Chinese facility after finding contamination risks.

Italian inspectors recommended the European Medicines Agency pull the manufacturing approval for and ban the heparin from Yibin Lihao Bio-technology after they found significant issues at its facility in Yibin, Sichuan, China, during an October inspection.

There are few details in the report the EMA posted to its EudraGMDP site, but it said investigators found two dozen violations, seven of them major, at the maker of crude heparin, an anticoagulant. Those included risk of contamination, unsatisfactory traceability of starting material, poor materials management and recovery of solvents as well as issues with buildings, facilities, equipment and storage.

Johnson & Johnson shares swoon as pharma giant loses yet another fight to protect Zytiga sales

Johnson & Johnson lost its latest effort to fend off Zytiga generics in court, sending investors reeling at the prospect of losing blockbuster sales. But the pharma giant says it’s now planning a last-ditch stand at the U.S. Supreme Court.

In two decisions during Thanksgiving week, the U.S. Court of Appeals for the Federal Circuit rejected J&J’s request for an injunction that would block generic launches while a patent lawsuit plays out. Generics makers could now launch their copycats, albeit at risk of penalties if J&J wins in the long run. But analysts remain unsure just when the cheaper copies will launch.

The decisions follow an October district court ruling nixing a key Zytiga patent, the so-called ‘438 patent, but granting a temporary injunction blocking generics. J&J had appealed the lower court’s decision in hopes of protecting Zytiga’s $1.22 billion in U.S. sales. (cr. FiercePharma)

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

The U.S. Food and Drug Administration today posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

The U.S. Centers for Disease Control and Prevention (CDC) warned in August that clinical effects of tianeptine abuse and withdrawal can mimic opioid toxicity and withdrawal. The CDC also reported there has been a rise in tianeptine exposure calls to U.S. poison control centers during 2014–2017, suggesting a possible emerging public health risk. Tianeptine is approved to treat depression in other countries, and taking it can have significant health effects, including neurologic, cardiovascular, and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal. (See more details on FDA)

Novartis scores FDA nod for new Promacta use—and hops in the fast lane for another

Novartis said Friday that the FDA approved Promacta for the first-line treatment of severe aplastic anemia (SAA) in adults and children two years and older, in combination with immunosuppression. It also granted a breakthrough designation to the drug for use in treating acute radiation syndrome, more commonly called radiation sickness.

Sales of Promacta grew 37% year over year in the first nine months of this year, to $844 million. A spokesperson for Novartis didn’t provide specifics about how the size of the patient population could grow with the latest label expansion. Severe aplastic anemia is rare: two out of every 1 million people in Europe and North America are diagnosed with the disease each year, he said.

As for radiation sickness, that market is effectively nonexistent, because Promacta would only be used to protect people in the event of a nuclear accident or attack.

“We hope that it will never have to be used,” the spokesman admitted. “However, we will be prepared if called upon.” (see more details on FiercePharma)

U.S. biotech focused on China to build manufacturing facility there

A U.S. biotech that bought a portfolio of nearly 30 generic drugs from Sandoz in January says it has plans to build its first manufacturing facility in China, where it has focused much of its drug development efforts.  

Rockville, Maryland-based CASI said on Friday that it “has entered into framework agreements” to build a manufacturing site at the Wuxi Huishan Economic Development Zone in Jiangsu Province, China.

CASI provided no details about the agreements in terms of cost or size of a facility, saying only that it expects construction to begin in the middle of 2019 and the facility will be able to handle large-scale production.

“We are excited about moving forward with building our own manufacturing site as part of our supply chain,” CASI Executive Chairman Wei-Wu He, Ph.D., said in a statement. “The facility will be a core component of our long-term growth strategy as it will give us significantly greater capacity in order to meet the company’s commercial needs, and also will allow us greater control over quality, cost of goods and to accelerate production schedules.”