Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines.

Efforts at Abbvie Inc. to selectively target voltage-gated sodium channel subunit alpha Nav1.7 to treat pain led to the discovery of quinoline and quinolone agents and, through structure-activity relationship studies, the candidate product ABBV-318. While Nav1.7 potency could be achieved with earlier compounds, efforts were required to improve characteristics including hERG activity, pharmacokinetics and selectivity over Nav1.5, yielding compounds which blocked Nav1.7 as well as another target for treating pain, Nav1.8.

As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.

Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.

How many patents does it take to violate U.S. antitrust law? That question isn’t a lead-in to a lame joke. Neither is it a valid question for a patent challenge, according to the U.S. Court of Appeals for the Seventh Circuit, which Aug. 1 affirmed the dismissal of a payer suit against Abbvie Inc. that claimed the North Chicago drug company violated the Sherman Antitrust Act when it obtained 132 patents on Humira (adalimumab) and then invoked them against biosimilars.

Targeted protein degradation (TPD) specialist Plexium Inc.’s potential $565 million deal with Abbvie Inc. came on the heels of a tie-up with Amgen Inc. in February worth as much as $500 million-plus, as well as an oversubscribed $102 million financing the same month – all of which translates into “optionality, moving forward, to keep our heads down, do the work we’re really good at and continue to watch the market,” said CEO Percival Barretto-Ko.