Samsung Touts Short Biosimilar Timelines, AbbVie Builds Portfolio Behind Humira: Third Day of J.P. Morgan Healthcare Conference

On the third day of the 36th Annual J.P. Morgan Healthcare Conference, Samsung Biologics, which forms Samsung Bioepis together with its partner Biogen, explained that its success is driven by short development timelines for its biosimilar products. Meanwhile, AbbVie, maker of the blockbuster Humira, featured its arsenal of products that could help insulate the drug developer from biosimilar adalimumab competition.

Samsung Focuses on Short Biosimilar Development Timelines

Taehan Kim, president and CEO of Samsung Biologics, described his company’s success with—and upcoming plans for—biosimilars. Saying that the company would maximize its revenue potential by adding more products to its pipeline, Kim explained that Samsung would minimize the development and approval timeline for its products through concurrent processing and execution.

“We apply a concurrent development strategy, including phase 1 and phase 3 simultaneously,” said Kim. “We try our best to minimize our development costs, to minimize the cost of goods of the biosimilar product. Also, we had a very successful marketing launch in 2016 through the global marketing partnerships, including Merck and Biogen.”

Kim highlighted Samsung’s recent successes with FDA and/or EMA approvals of its etanercept, infliximab, adalimumab, trastuzumab, and insulin glargine molecules. Additionally, he reported that Samsung’s bevacizumab biosimilar candidate is in phase 3 clinical development, and that its proposed rituximab biosimilar, being developed with partner Archigen Biotech, is in phase 1 and phase 3 concurrent development.

Samsung’s revenue has grown steadily after launching its biosimilars, reported Kim: in the third quarter of 2017, Samsung’s etanercept biosimilar generated $99.2 million in sales, up from $30.8 million in the third quarter of 2016.

AbbVie Shifts from Humira to a “Portfolio of Therapies”

Richard Gonzalez, chairman of the board and CEO of AbbVie, said that upadacitinib and risankizumab will sustain its leadership in immunology as Humira’s patent protection reaches expiry. AbbVie will “…evolve from a single product to a portfolio of therapies,” said Gonzalez.

AbbVie expects that upadacitinib, an oral Janus kinase (JAK) inhibitor, is expected to launch in 6 indications by 2022, starting with an indication in rheumatoid arthritis in 2019. Risankizumab, an interleukin-23 inhibitor, is expected to launch in 4 indications by 2023, starting with an indication in psoriatic arthritis in 2019.

Gonzalez also reported that AbbVie is in early-stage development of an antibody—drug conjugate of an anti–tumor necrosis factor therapy and a steroid, as well as a CD40 antagonist and a JAK–Bruton tyrosine kinase inhibitor combination.

Despite developing these new therapies to help defend AbbVie’s share of the market for inflammatory diseases after Humira becomes subject to biosimilar competition, Gonzalez said that AbbVie expects Humira sales to approach $20 billion by 2020, and to remain a significant part of its cash generation through 2025 “and beyond,” as biosimilar competition will be, AbbVie predicts, “manageable.”

Interestingly, Gonzalez said that direct biosimilar competition for Humira would begin, at the earliest, in 2022; AbbVie and Amgen recently announced a settlement that will allow Amgen to market its FDA-approved biosimilar adalimumab, Amgevita, in the United States beginning in 2023.