Coherus, Pfizer, and Teva Look to Year Ahead at J.P. Morgan Healthcare Conference

On the first day of the 36th Annual J.P. Morgan Healthcare Conference, biosimilar developers Coherus, Pfizer, and Teva all laid out their strategies for the year ahead.

Cohreus Has “Very Good Reason to be Optimistic” About Pegfilgrastim Biosimilar

Coherus’ CEO, Dennis Lanfear, highlighted his company’s progress on CHS-1701, a proposed pegfilgrastim biosimilar that received a Complete Response Letter (CRL) from the FDA in June 2017.

Lanfear reported that, in response to the FDA’s concerns—acknowledging that “[the FDA] are being appropriately cautious” about immunogenicity—Coherus redeveloped and validated its immunogenicity assay for the drug, and has discussed its validation with the FDA. It also reports that it has addressed manufacturing issues related to the proposed drug.

Currently, the company is preparing to resubmit its pegfilgrastim Biologics License Application to the FDA and to submit a marketing authorization application to the European Medicines Agency (EMA). Lanfear said that Coherus expects a 6-month FDA review cycle, putting the drug’s potential US approval on track for the third quarter of 2018, as well as potential European approval by mid 2018.

Lanfear also reported that CHS-3351, a proposed ranibizumab (Lucentis) biosimilar, would initiate clinical development in 2018, and that CHS-2020, a proposed aflibercept (Eylea) biosimilar has initiated preclinical development.

Coherus’ anti—tumor necrosis factor (anti-TNF) biosimilars—CHS-0214, a proposed etanercept biosimilar, and CHS-1420, a proposed adalimumab biosimilar—continue to face legal delays; Coherus has pending inter partes review petitions concerning patents covering etanercept (institution decisions are expected in March 2018), and the company is also awaiting patent expiry for reference adalimumab.

Despite Coherus’ potential in ophthalmology and anti-TNF candidates, Lanfear said the company is currently “focused very tightly” on pegfilgrastim, seeking to “block and tackle our way right through the [CRL].”

Pfizer’s “Rich Data Delivery Year” for Innovator Products

Mikael Dolsten, MD, PhD, president of worldwide research and development for Pfizer, said that, far from seeking to be “a follow-on company,” Pfizer, developer of 2 FDA-approved infliximab biosimilars, Inflectra and Ixifi, is focusing heavily on bringing innovator products to the market.

Saying that the company “focused on rigorous science [and] crisp decision-making” to reallocate resources away from its neuroscience research division, Dolsten reported that Pfizer has the potential for up to 15 “blockbuster approvals” by 2020, including 5 products in oncology (inclusive of targeted cancer agents), a Janus kinase (JAK) 1 inhibitor for the treatment of atopic dermatitis, and a JAK ‘X’ for the treatment of alopecia and vitiligo.

Subject to attrition, said Dolsten, sales of Pfizer’s potentially approved drugs are anticipated to exceed $1 billion in the coming 5 years.

2018 will also be “a rich data delivery year,” said Dolsten, with:

• US and EU action dates for its JAK inhibitor Xeljanz in ulcerative colitis
• Phase 3 data forthcoming for the novel biologic tanezumab for the treatment of pain
• Phase 1 data for a JAK3 inhibitor for the treatment of rheumatoid arthritis
• Phase 1 data for an anti—IL-33 drug for the treatment of atopic dermatitis
• Phase 1 and 2 data on TFPImAb for the treatment of hemophilia
• Phase 2 data on selective JAK inhibitors

Teva Is “Not Chopping Up the Company”

Kare Shultz, president and CEO Teva, which is jointly developing biosimilars referencing rituximab and trastuzumab with Korean drug maker Celltrion, tried to allay investor concerns about the company’s major restructuring, which has included layoffs of 14,000 workers.

“We…are divesting some of our non-essential assets,” Shultz said. “We are not chopping up the company. We are going to optimize and make the way we provide our products more efficient.”

That efficiency will be provided through consolidation of offices, layoffs in research and development departments, the shuttering of factories, and reductions of active pharmaceutical ingredient sites from 80 to approximately 8 to 10.

With savings generated by these cutbacks, Teva plans to pay down its $3.2 billion in debt.

Shultz put a positive spin on his report, saying that the company still has the ability to do early clinical trials, which are “some of the best in the world,” and that “We’ll launch more generics and biosimilars than anyone else.”