Tag: Adello Biologics

Biosimilar Maker Adello Biologics Bought by Pharma Research Company

The assets of biosimilar drug developer Adello Biologics were sold to Kashiv Pharma, LLC, the companies announced on January 4, 2019. The new company will now be known as Kashiv Biosciences, with its headquarters in Bridgewater, New Jersey.

Adello Biologics

Adello Biologics had been one of a handful of “pure-play” biosimilar companies, in that it was not involved with any other pharmaceutical sectors. Its two biosimilar products in most advanced development (filgrastim and pegfilgrastim) would be subject to heavy competition if approved. The acquisition by Kashiv now broadens the pipeline. In a press release, Kashiv cited “As a result of the acquisition, Kashiv BioSciences’ broad business offering includes drug delivery platforms incorporating delayed-release technology and gastric retention systems that improve the efficacy and safety of known drugs; a 505(b)(2) pipeline of seven development products targeting unmet clinical needs.” It does not appear that any of the 505(b)(2) agents are currently being evaluated for approval by the FDA.

A privately held company, it had been known as Therapeutic Proteins International since November 2016. Adello filed for Food and Drug Administration (FDA) approval for its filgrastim biosimilar in September 2017, with a decision expected in the third quarter of 2018. The delay in approval lends speculation to the possibility that FDA issued a complete response letter to the company. This filing was based on the submission of phase 1 data only. In March 2018, Amgen filed a lawsuit against Adello in New Jersey District Court, claiming patent violations and that Adello failed to follow the necessary biosimilar development protocol outlined by law.

The company’s pegfilgrastim biosimilar (TPI-120) had completed two phase 1 studies by the beginning of 2018, and it was hoped that the company would submit its FDA 351(k) application before the end of the year. Executive Vice President & Chief Business Officer Pavan Handa confirmed in an E-mail that the pegfilgrastim program “is in active development and we continue to make significant progress towards a filing. ”

Adello’s journey highlights the potential financial problems that biosimilar-focused companies may face. As a privately owned company, its capitalization was likely limited, and delays in reaching the market become even more critical for companies without other revenue-generating products. The deal with Kashiv breathes new life into the enterprise, but Kashiv, too, does not yet have an approved biosimilar product (nor approved innovative drugs) to its credit. Before the acquisition, Kashiv had focused on “applying novel technologies to improve the delivery of compounds with otherwise problematic physical and/or chemical properties” and on abuse-deterrent technologies for opioid products.

It appears to us that the purchase of Adello by Kashiv, another private company, is an effort at doubling down, to attain more immediate revenue from drug sales.

FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further

When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation.

The FDA has been a bit fuzzy with respect to when an FDA Advisory Committee will be necessary. In the past, however, these AdComms had been required for all first biosimilar approvals to a new reference product. This was the case for filgrastim, infliximab, etanercept, trastuzumab, bevacizumab, adalimumab, and epoetin. Second biosimilars did not always require an AdComm, most recently last September with Boehringer Ingelheim’s Cyltezo®, the second adalimumab approved by FDA.

FDA Advisory CommitteeVarious problems with the 4 pegfilgrastim biologic license applications and resubmissions have provided the FDA ample time to review data and mull the consequences of approval or rejection. This case could be an exception. A greater challenge may be upcoming though.

Not that a great deal was achieved with the biosimilar AdComms. In general, votes for recommended approvals have been unanimous or lopsided. A recommendation for approval does not always result in approval—sticky manufacturing issues have gotten in the way (e.g., for Pfizer’s Retacrit). The FDA Advisory Committee meetings does give the public and other stakeholders a chance to air their views. Generally, this has been not for or against the biosimilar being reviewed but for or against biosimilars as a whole.

In March, I raised the case of Adello Biologics, which is attempting to gain approval of its filgrastim biosimilar without any phase 2 or phase 3 clinical data. This may be the second filgrastim biosimilar approved, so the FDA can avoid an AdComm on this basis. More importantly though, this agent could be the first biosimilar approved without any patient-based clinical testing (phase 1 is usually conducted in healthy volunteers). The next FDA Blood Products AdComm is not scheduled until November 29, 2018, and we do not know if Adello’s product will be part of that discussion. With a submission date of September 2017, one would expect a decision from FDA in the third quarter of this year.

In other biosimilar news… Celltrion resubmitted its 351(k) application to the FDA for its biosimilar version of trastuzumab. The original application resulted in an April 5 complete response letter for the Celltrion/Teva team.