JPM: Coherus sticks to 2018 timeline for Humira biosimilar
Coherus BioSciences is taking a multi-pronged approach to promoting CHS-1420, its Humira (adalimumab) biosimilar candidate, stating on Tuesday that "additional legal actions may be filed in the near term" in its ongoing effort to enter the highly lucrative market.
Also on Jan. 10, Coherus reiterated that it anticipates submitting a Biologic License Application (BLA) in the first half of 2017 for the drug.
What's more, the California-based biopharma released further positive results from its ongoing Phase 3 study of CHS-1420 in psoriasis patients. From week 16 until the study ended at week 24, three treatment groups — one that took just the biosimilar, one that took just Humira, and one that switched between the drugs — maintained 75% improvement in the psoriasis area and severity index. Humira and CHS-1420 were similarly well-tolerated by all three groups, the company said.
Biosimilar developer Coherus is considered among the front-runners in a crowded field vying for inclusion in the blockbuster Humira market.
The company's reiteration of the anticipated timeline for its Humira biosimilar is noteworthy given the U.S. Patent Trial and Appeal Board's decision in November 2016 not to review a key patent held by AbbVie for Humira.
Following the board's ruling, Jefferies analysts said it could significantly delay any future launch of Coherus's biosimilar. Indeed, the analysts described it as unlikely that any Humira biosimilar would reach the U.S. market before 2023.
Yet at the JPM conference, Coherus discussed additional strategies to support its biosimilar's path to market in 2018, while also saying it anticipates 2017 will be a “transformational year” for biosimilars in terms of first product approvals and potential launches.
On the legal side, Coherus said it would continue to advance defensive and offensive intellectual property (IP) strategies to address ongoing formulation IP risks. And on the clinical side, Coherus said it expects to initiate a pharmacokinetics study in the first half of 2017.
Interestingly, Coherus' discussion of its Humira biosimilar was nestled in its conference presentation among discussions of other product candidates. For example, the company cited “significant near-term commercial opportunity” and described itself as well-positioned for its CHS-1701 pegfilgrastim biosimilar for oncology treatment. Coherus then discussed what it sees as market opportunity for its CHS-0214 etanercept biosimilar.