Despite what the New York Times and its echoers have said, makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it’s not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.’s Omontys (peginesatide). Although Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes...

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...

I recently took a few months off from daily deadlines to explore the evolving world of biosimilars for the newest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. It was quite an eye-opening adventure. Even though I’ve been covering biosimilars for BioWorld for a few years now, I was surprised at the impact these follow-on biologics (FOBs) are having throughout the world, given that the European Union (EU) is continuing its two-year approval slump and no biosimilar candidates have stepped up to bat yet in Canada or the U.S. Some of my surprise undoubtedly...

“Hey kids, let’s put on a show!” That was a famous line from the 1937 Broadway musical, Babes in Arms, shouted to exhort the old gang to take action to save the orphanage. As the theater market just put on its Tony Awards to assess the state of its industry, June is also the most active event season for biopharma, as the industry puts on its own long-running show, with the ASCO and BIO events taking center stage this month. Only this time, it’s not the orphanage that’s in need, but the orphan drugs – as well as the biosimilars,...

The contenders for becoming the April Fool in Life Sciences for 2012 came down to three candidates, but two of them have persisted past the April 1 deadline, thereby removing themselves from consideration. President Barack Obama still has a glimmer of hope for preserving his Affordable Health Care for Americans Act and even if that is struck down, he can still overcome his supreme pranking with a wily November trick-up-his-sleeve snappy comeback. And Illumina Inc.’s stockholders continue to resist drinking Roche’s undervalued Kool-Aid unless they add more sugar to sweeten to Illumina’s taste. So, to the would-be biosimilars drugmakers –...

You think the drug shortage is a devil now Just wait around a few years ’Cause you ain’t seen nothin’ yet. When that biosimilar pathway begins to flash Those big green dollar signs, You’ll know, you’ll know, you’ll know, you just ain’t seen nothin’ yet. Those biosimilars will turn your heart away from the old drugs of yesterday. You’ll think you have it comin’, and you’ll want it that way. You’ll say big profits are good profits, so you’ll take what you can get. B-B-B-Baby, you ain’t seen n-n-n-nothin’ yet. Patients will go to the doctor, and he’ll tell them...

Regulatory certainty. It’s something industry needs and investors want to see. It’s also one of the drivers for job creation. But it’s something our government doesn’t seem to get. Take the president’s repeated call for shorter data exclusivity for biologics, beginning in 2012. Just last year, Congress made 12 years the law of the land. Changing it now is a) premature, b) unnecessary and c) absolutely pointless. As we’ve reported in BioWorld Today, the FDA is not ready to be deluged with biosimilar applications. And the biosimilar user fees that will pay for the path won’t even be in place...