WASHINGTON -- Industry stakeholders and one lawmaker discussed ways to balance innovation and affordability in the specialty drug market during a panel discussion Wednesday.
At the meeting hosted by The Atlantic and sponsored by The Biosimilars Council, stakeholders also discussed the "patent dance," specifically a lawsuit under review by the Supreme Court, whose decision could significantly impact the future of biosimilars -- either accelerating their entry to market or delaying it.
Five biosimilars have received approvals in the U.S. compared with over 20 in the European Union.
Biologics are large complex molecules that have been used as treatment for cancer, rheumatology, and inflammatory bowel disease. Unlike most common medications -- small molecule drugs that are chemically synthesized -- biologics must be produced in living organisms such as yeasts and bacteria. They may include vaccines, blood and blood components, somatic cells, tissues and gene therapies, according to the FDA.
Biosimilars are drugs that are deemed "highly similar" to innovator biologic agents with "no clinically meaningful differences."
Unlike generic drugs, in which the active ingredients are identical to the one in brand name drugs, producing a 100% identical biologic is not possible. Their complex manufacturing process results in slight differences between batches for both biologics and biosimilars.
The lawsuit Amgen v. Sandoz now before the Supreme Court hinges on two issues: whether biosimilar manufacturers are required to share their drug applications with originator's manufacturers, and how long biosimilars must wait before beginning to market their products, explained Courtenay Brinckerhoff, JD, a partner at the Foley and Lardner law firm here.
Specifically, the case asks the court to decide whether biosimilars must give originator companies 180 days notice before marketing as current law requires, and whether such notice can be given prior to FDA approval, Brinckerhoff continued.
The lawsuit also asks, in cases where a biosimilar applicant does not provide the drug application information and related manufacturing information, if the only avenue for an innovator drug (the biologic manufacturer) should be legal action, according to SCOTUSBlog, which provides a detailed timeline of the lawsuit a summary of the argument and analysis.
Sandoz received approval for its Zarxio, a biosimilar to Amgen's filgrastim, in 2015.
The case centers around language in the Biologics Price Competition and Innovation Act (BPCIA), which was signed into law by President Obama in 2010. That bill aimed to do for biosimilars what the 1984 Hatch-Waxman Act did for generics: lay out a regulatory pathway and outline the protections given to brand name, or in this case, biologic drugs.
Specifically, BPCIA offered an abbreviated licensing vehicle that involves analytical studies, animal studies, and may be supplemented with clinical studies when necessary.
Regarding the lawsuit itself, the language of the law dictates that biosimilars "shall" be required to share its application, and shall give 180 days notice before marketing, which means keeping the drug off the market for approximately 6 months even after the FDA has approved it. This is after the current biologics' patent exclusivity period of 12 years has expired.
"Shall meant shall," said Bruce Artim, JD, director of federal affairs at Eli Lilly, adding BPCIA was never intended to be a "discretionary system."
"Congress certainly didn't want to have the innovators put in the position where all of a sudden there are these surprise attacks on patents," he said.
Philip Nickson, JD, PhD, associate general counsel of Intellectual Property for Momenta Pharmaceuticals, said it was important to distinguish between good patents and bad ones.
"There are certain patents out there for certain molecules that I think we would all agree don't protect new cures, but are rather designed to delay patient access through abusive litigation and various other strategies," he said.
With regard to the "optionality" of the provisions, Nickson said he believes that should be decided on a "case-by-case" basis.
In a separate, earlier panel discussion, Rep. Peter Welch (D-Vt.) whose first wife died of cancer, said he favors bringing biosimilars to market more quickly and believes they will help lower costs.
"If you have a breakthrough drug, but the cost is so out of reach you can't afford it, then [despite] the life you save ... you're going to kill folks with the price," he said, adding that a lot of biologics companies have also tried to extend their patents in "sketchy" ways.
"There's got to be some government role here to protect the consumer against overreach," he said.
Welch has co-authored the "The FAST Generics Act" with Rep. David McKinley (R-W.Va.) which aims to allow drug firms to get the products they need in order to reverse-engineer biosimilars when the exclusivity period for innovator products runs out, he said.
He also supports a shorter patent exclusivity period for biologics at 7 years, rather than 12 years. On Tuesday, he introduced an amendment to the FDA Reauthorization Act to allow importation of drugs from Canada.
Asked whether he was concerned that importation might drive up the cost of drugs in other countries, Welch said the U.S. already pays the highest prices for drugs while also funding the innovation.
"And the question I have is whether the benefit of innovation goes everywhere to every country. Shouldn't every country contribute to the cost of innovation?" he said.
While Welch said he's not certain prices would rise in other countries because of importation, he re-emphasized to MedPage Today that currently U.S. taxpayers and consumers are bearing the full burden of innovation.