SAO PAULO, Brazil – Pharmacovigilance is emerging as a key concern for the development and distribution of biosimilars in Latin America. Experts gathered this week for the BIO Latin America conference focused on the issue and highlighted what they see as a key concern, one that is holding back the spread of that new class of drugs throughout the region.

Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices.

HONG KONG – Samsung Bioepis Co. Ltd., a South Korean biosimilar developer, said the FDA approved its July 2018 application for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbvie Inc. blockbuster TNF-blocker Humira (adalimumab).

HONG KONG – Celltrion Inc., of South Korea, and Hong Kong-based conglomerate Nan Fung Group Holdings Ltd. said they have built a joint venture named Vcell Healthcare Ltd., geared toward the Chinese market. 

HONG KONG – Supported by the municipal government of Chongqing in China, a joint venture between South Korean drugmaker Binex Co. Ltd. and Chinese pharmaceutical company Chongqing Zein Pharmaceutical Co. Ltd. will be set up in the third quarter of this year.

Unintended consequences. It’s a term that’s bandied about all too often in Washington these days, as it’s become the PC way for lawmakers and agencies like the FDA to save face when they have to admit, “Oops, we didn’t think that one through very well” when confronted with the negative impacts of the laws and regulations they’ve created. A new unintended consequence could be in the offing as the FDA extends its practice of label carve-outs to biosimilars. A familiar feature of the generics scene, carve-outs have allowed the agency to approve a knock-off even though the reference drug may...

It’s not every day that drugmakers get a chance to take on an entirely new market. Biosimilars are offering that opportunity. And hundreds of drugmakers, research institutions and governments are hoping to make the most of it. The result is more than 700 follow-on biologics (FOBs) already approved or in the global pipeline, according to a new report by BioWorld. Those entering the field are as diverse as the FOBs they’re developing. Biologics pioneers, big pharma and generic drugmakers are being joined by “pure-play” start-ups, conglomerates, public-private consortia, contract manufacturers, contract research organizations, government agencies, nonprofits and research institutions. Some...

It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there still is no telephone competition. The Soviet Union leads a boycott of the Summer Olympics being held in Los Angeles, presumably as payback for the U.S. boycott of the 1980 Moscow Games, which was, in turn, a response to the Soviet war in Afghanistan. Even though Time named the computer the “Machine of the Year” two years ago, personal computers...

"If you plan to be around five or 10 years from now, you have to have a Chinese strategy." That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex Pharmaceuticals Inc., and now executive chairman of Alkeus Pharmaceuticals Inc., had just returned from China where Shanghai Syntheall Pharmaceuticals Co. Ltd., a manufacturing subsidiary of Wuxi Apptec Co. Ltd., is the manufacturing site for starting materials for Vertex's hepatitis C drug Incivek (telaprevir). A combined massive government investment, a growing appetite for capitalism, and a shift from pharmaceutical industry service...

What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities, they say biosimilars and their reference product should share the same international nonproprietary name (INN) – as is the practice with traditional generic drugs. That’s the argument the Generic Pharmaceutical Association (GPhA) made in the citizen petition it submitted to the FDA earlier this month. Used to cashing in on the success of a small molecule brand drug by sharing...