Tag: licensing agreements

Multiple Sources Announce Pfizer’s Intended Launch of Bevacizumab Biosimilar December 31, 2019

After coming to a settlement agreement (which may have been prodded by Amgen’s launch of Mvasi® in July), Pfizer can launch Zirabev® at the end of this year.

First reported by Aiden Fry at The Pink Sheet and confirmed by Kelly Davio at the Center for Biosimilars, the settlement between Genentech and Pfizer was signed September 19. It clears all remaining patent suits filed by Genentech (and its parent Roche), and if it follows the standard terms of previous agreements, pays a license to the maker of the reference product (Avastin®).

Amgen decided to launch Mvasi at-risk, gaining the advantage of being the first bevacizumab biosimilar available for prescription. The legal case brought by Genentech against Amgen hinges less on patent infringement but more on whether 6-month notice of launch was provided (or needed). The next step in this case is reportedly a trial sometime in 2020.

At least five other bevacizumab biosimilars are actively being investigated, but none of these are likely to be approved in 2020 (none have filed 351[k] applications to date).

Momenta Drops Out of Biosimilar Adalimumab Competition

In reporting its second quarter earnings, Momenta Pharmaceuticals stated on August 2 that it no longer plans to market M923, its biosimilar version of Humira®.

“Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

In 2018, Momenta decided to drastically scale back its biosimilar development as part of a strategic review. However, it continues to partner with Mylan on one remaining biosimilar candidate, M710. This is a biosimilar version of aflibercept (Eyela®).

Momenta’s troubles were first apparent after it completed its phase 3 trial of M923 in psoriasis. The clinical study pitted the biosimilar versus the EU-licensed version of adalimumab, and was successfully completed in 2017; however, no FDA filing ensued, despite a company announcement that it would occur in 2018. Later that year, the company stated that it delayed filing for financial reasons, but it would continue to seek a partner to commercialize the product.

In 2018, it signed a licensing agreement with AbbVie, which would have allowed it to launch in December 2023—in the back of the pack of licensed biosimilars in terms of timing (which could not have helped its efforts to seek a partner). In view of its refocusing its strategic outlook, the delay in filing a 351(k) biologic licensing application (BLA) application with the FDA may have made some sense from a couple of perspectives

First, the company may have thought twice about continuing expenditures if it was undecided as to whether it would remain committed to the biosimilar development. These expenditures could be quite significant (beyond payment of user fees) if the FDA requested additional data in an initial review of the BLA.

Second, with a potential launch date of December 2023, Momenta certainly had time to get its ducks in a row. If a commercialization partner could be lined up before the BLA filing, that company could help shoulder additional associated costs.

In any case, Momenta’s pull back is not entirely unexpected. Though it intended to file an application with the European Medicines Agency early this year (which would not have required a further delay in launch), this also did not occur (probably because of existing biosimilar adalimumab competition in Europe).

Momenta’s pipeline, beyond aflibercept, consists of other biologics for rare diseases. Its marketed products are for generics of Copaxone® and Lovenox®.

Amgen/Allergan Partners Announce Launches of Herceptin and Avastin Biosimilars

The partnership of Amgen and Allergan made a huge splash in the biosimilar market by announcing the simultaneous US launches of the first two biosimilars of anticancer monoclonal antibodies. The agents Kanjinta® (trastuzumab-anns) and Mvasi® (bevacizumab-awwb) were officially made available July 18.

The move occurred almost simultaneously with a court denial of Genentech’s request for a restraining order against Amgen. For Amgen, this marks the first two biosimilars to reach commercialization.

The launch discounts associated with these two agents is only 15% off of average wholesale price (AWP), but the manufacturers point out that is still significantly below the average selling price (ASP) of the two reference drugs—13% lower than that for Herceptin® and 12% lower than that for Avastin®. This pricing does not include potential rebates or discounts that could further reduce the net costs of these biosimilars.

The launch timing raises the question of when the FDA-approved biosimilar competition will be launched. Other biosimilars in the trastuzumab space have signed licensing agreements with Genentech, the maker of Herceptin. Their launch dates have not been disclosed. Several biosimilar makers have also signed licensing agreements with Genentech on their versions of Avastin, and their launch dates may be upcoming as well.

Assuming the licensing agreements compel the other manufacturers to pay some percentage of sales or profits to Genentech, this could give Amgen/Allergan an automatic edge in profitability. It is unknown whether the launch timing of Mvasi and Kanjinti, have any implications for the existing licensing agreements. For example, it may be possible that an early launch by an unlicensed competitor could negate specific clauses of these contracts.

The bevacizumab biosimilar class progress had stagnated through court proceedings and licensing agreements. In a post from January 2019, we had noted that Amgen had notified the court that it was prepared to launch as early as April 2018.

On the trastuzumab side, Amgen/Allergan’s product was the most recently approved biosimilar (in June 2019).

In their joint press release, they quoted Paula Schneider, CEO of the Susan G. Komen Breast Cancer Foundation. “The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers,” she said. “As patient advocates, we are working to ensure that patients are educated about biosimilars and understand that these FDA-approved treatments are just as effective as the original biologic drugs.”

Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar

And then there was one. Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant®, an approved Herceptin® biosimilar. A Joint Stipulation of Dismissal is usually the confirmation that a licensing agreement has been reached.

This leaves one remaining approved trastuzumab biosimilar maker that has not settled with Genentech (a subsidiary of Roche). Amgen’s product Kanjinti®, which was the last trastuzumab biosimilar approved (in June), is the last of 5 approved agents that is not yet subject to a Genentech agreement. The other manufacturers, Mylan/Biocon, Teva/Celltrion, Pfizer, and now Samsung Bioepis, will likely pay a royalty to Genentech whenever their products are launched.

Launch dates have not been announced (nor have the terms of these agreements) for any Herceptin biosimilar. However, the principal patent for Herceptin® has expired, so biosimilar competition should be available before the end of the year.

In other biosimilar news…Coherus Biosciences announced that it has manufactured its 400,000th dose of its pegfilgrastim biosimilar Udenyca®. Additionally, its unaudited second quarter earnings seem to indicate positive movement, as much as $84 million (more than doubling first-quarter earnings of $37 million).

Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?

As reported by the Center for Biosimilars, a union has filed a class-action lawsuit against AbbVie and the eight prospective biosimilar adalimumab makers who agreed to delay bringing their agents to market through a royalty arrangement.

Only Boehringer Ingelheim remains as a biosimilar maker who has an approved version of adalimumab but who has not signed on with AbbVie. United Food and Commercial Workers Local 1500 has filed the suit with the other manufacturers and AbbVie, claiming that by their actions, they are trying to “divide the market for adalimumab between Europe and the United States,” according to the Center for Biosimilars report.

This is an interesting question. The individual motivations of the first companies to come to agreement with AbbVie (Amgen, then Samsung Bioepis) included an end to interminable patent legislation in the US. They wanted the ability to immediately plan launches in Europe (starting in October 2018). The motivations of most other subsequent signees almost certainly was to not forfeit marketshare in Europe, which was needed to help sustain biosimilar development efforts for the US market. In fact, many of these prospective US manufacturers already had received approval in the EU.

AbbVie’s principal patents on Humira® expired in Europe in October 2018. The last of the principal patents are supposed to expire around 2023 in the US anyway. Was it necessary to arrange serial US launches as demonstrated in this link? Would patent litigation have continued well past the supposed patent expiration date? Knowing AbbVie, this is likely. Their several patents involving adalimumab use to treat individual diseases would provide AbbVie a basis for forging ahead with lawsuits that would have gained them additional billions of dollars in sales while the suits meandered toward conclusion.

Does this mean that access to Humira is accelerated through the signing of the royalty agreements, rather than delayed through acts of collusion? That is difficult to say. Although should the lone holdout—Boehringer Ingelheim—decide that it makes business sense to launch at risk, it could topple the carefully orchestrated structure of the agreements. Amgen believes that it will launch the first adalimumab biosimilar, and experience a few months of exclusivity in the US. At that point, Amgen (and every subsequent adalimumab biosimilar maker) would have to decide whether (1) to do the same or risk losing its advantage, (2) start working towards marketing plan B, or (3) cede the initial marketshare and its billions in revenue and wait it out. If Boehringer obtains its sought after interchangeability designation, that may well speed up the process.

Personally, I find it hard to believe that these individual acts represent premeditated collusion; although the resulting lack of access to the many biosimilar versions may look to others as an orchestrated maneuver.