UPDATE: Oct. 10, 2018: President Donald Trump signed the bill into law at a ceremony held in the White House's Roosevelt Room on Wednesday afternoon.
- President Donald Trump signed a bill into law Wednesday requiring drugmakers to send details of biosimilar deals to the Federal Trade Commission for antitrust scrutiny.
- The legislation will tweak the Medicare Modernization Act of 2003 governing generic drugs to include biosimilars for FTC review of settlements between biologic and biosimilar developers. Additionally, the new law will ban so-called gag clauses that prevent pharmacists from telling patients when paying out-of-pocket instead of through insurance for drugs would be cheaper.
- The biosimilar addition was part of the Patients Right to Know Drug Prices Act, one of two laws the president signed Wednesday. The other bill enacted into law was the Know the Lowest Price Act, which also dealt with gag clauses.
In the still-developing area of U.S. biosimilar law, this revision provides a morsel of clarity on the regulatory framework drugmakers can expect from the agency tasked with enforcing the nation's antitrust laws.
Michael Perry, a partner at the law firm Baker Botts, recently said the law wouldn't have a huge impact on the industry, but does help clarify the FTC's authority on reviewing such deals. Perry was counsel to the FTC's Bureau of Competition Director from 2015 to 2016.
However, Perry remarked the law will give FTC staff authority to access the terms of these deals without needing to seek additional authority from the commission.
"It gives them the green light from the get-go to look at any settlement without having to go through the usual hoops they have to go through," he said in an Oct. 4 talk on the topic.
The law will also allow the agency to track biosimilar deals and develop a data record of relevant terms, similar to how they've done with generics. This monitoring will inform FTC enforcement and advocacy strategies, Perry added.
Perry predicted biosimilar agreements are "really likely to attract antitrust attention" because of the large amounts of money involved and the wide range of settlement terms included in deals.
Amid heightened public scrutiny of drug prices and a rare area of agreement between Trump and Democrats, biologic copycats could be an important tool in lowering drug prices. But biosimilars have been slow to enter the market and sluggish in gaining market share, particularly in the U.S.
Perhaps no case better exemplifies this than AbbVie's mega-blockbuster Humira (adalimumab).
As the best-selling drug in the world, netting more than $18 billion in sales last year, Humira is set to face biosimilar entries in less than a week in Europe. Amgen and Samsung Bioepis both plan to launch their copies on Oct. 16.
But in the U.S., AbbVie reached deals with multiple drugmakers, including Amgen, Samsung Bioepis and Mylan, to stave off competition until 2023. At least one patient group previously criticized these deals and asked the FTC to investigate.
Sens. Susan Collins, R-Maine, and Claire McCaskill, D-Mo., introduced the legislation in March. The Senate and House both passed the bill in September, sending the proposal to the president's desk to be signed into law.