Imagine this interesting and perhaps very real-life scenario. It could have several implications for the present biosimilar marketing picture.

A reference manufacturer, we’ll call them Arby, signs multiple licensing deals with biosimilar manufacturers, to launch their products sequentially in 2025. The licensing deals all conclude outstanding patent litigation between the parties. But one biosimilar manufacturer doesn’t sign. We’ll call them Brooklyn Industries (BI for short).

Despite Arby’s contention that its patents on the reference product Yultira are valid until the year 2045, BI decides to launch at risk in July 2020. According to the phased launch schedule, another manufacturer, Thousand Oaks, was supposed to have the first biosimilar available on the market, with a three-month jump on the other seven competitors. Does that really give BI a five-year start over all of its competitors? And what if BI had an interchangeable biosimilar designation? Would that enable them to lock up the marketshare?

Biosimilar Licensing Deals: The Acceleration Effect

This scenario is actually playing out today with Amgen’s launch announcement of its trastuzumab and bevacizumab biosimilars (Kanjinti^® and Mvasi^®, respectively). Other manufacturers, including Pfizer, Samsung Bioepis, Mylan/Biocon, Teva/Celltrion have licensing agreements in place with Genentech (a subsidiary of Roche) for launch of their Herceptin^® biosimilars. Only Amgen’s Mvasi and Pfizer’s Zirabev^® are approved (so far) to compete for the bevacizumab business. The details of the licensing deals signed by Roche have not been released publicly, so we do not know when the first “authorized” biosimilars were supposed to launch. Conjecture abounded that it would be in 2019, nevertheless.

How does Amgen’s Kanjinti launch affect the licensing agreements that were signed with Roche? Does it mean that Amgen gets a substantial head start on the competition? Do the licensing contracts consider this possibility?

According to Kevin M. Nelson, JD, at the Chicago-based law firm Schiff Hardin, this scenario is considered in a typical pharmaceutical licensing arrangement. “Typically, settlement agreements in the pharma space include what are called acceleration clauses. Such clauses will allow an agreed-upon launch date to be accelerated to an earlier date in the event the patent or patents are invalidated or found not infringed in another litigation, or if a competing product or authorized competing product comes on the market before that agreed-upon date.”

He added that these acceleration provisions “can come in a variety of flavors from a change in royalty rate or structure, a requirement to leave the market if the ‘unauthorized entrant’ leaves the market, or perhaps agreed damages.” 

Accelerating Clauses Are One Thing. Accelerating Launch Is Another Matter

The fact that Amgen has announced its immediate launch may present more pragmatic problems for the other manufacturers, Mr. Nelson pointed out. Let’s say that you were a member of the Mylan/Biocon team. Your product was approved more than 18 months ago (the first one approved). Let’s also say that your licensing agreement with Genentech allowed you to launch after November 1 (a purely speculative, arbitrary date). Finally, assume that your licensing agreement was generous: it allowed you to launch as soon as possible after another competitor jumped the starter’s gun. Is it feasible to launch immediately, perhaps four months early?

“The biosimilar companies cannot just fire up the machines and have product ready tomorrow,” stated Mr. Nelson. There are all of the logistical issues surrounding a launch that must be considered: “Manufacturing, packaging, sales, and distribution all take time,” he said. “And you don’t want inventory to go bad—especially not this type as it is expensive. They may have some reserve lots or made small batches just in case, so we could see a trickle into the market.”

Remember, also, that payer and health system contracts are not arrived at overnight. Even if the Mylan/Biocon team did have lots available for shipment, they might not have places in the US to ship, other than to a group purchasing organization or distributor’s warehouse.

Typically, payers will not cover pharmaceutical agents outside of medical exceptions before the Pharmacy & Therapeutics Committee review, and this can happen anytime between 60 days and 9 months of the launch. And this is not a product that will revolutionize therapy or immediately fill an unmet clinical need. Only large discounts can move the needle here, and establish a contract quickly. Therefore, the anticipated short window of opportunity that Amgen may have in launching Kanjinti may get a little shorter but perhaps by not much.

When I mentioned the Arby, er Abbvie, scenario, Mr. Nelson agreed that it would be an entirely different ballgame. Had Boehringer Ingelheim decided to enter the market (as an interchangeable or not), their launch “would have caused absolute chaos.” Imagine trying to pull forward launch date plans of seven manufacturers by three years!