Amgen and Mylan Highlight Biosimilar Wins, Roche and Sanofi Look to Innovator Products in Second Day of J.P. Morgan Healthcare Conference

During the second day of the 36th Annual J.P. Morgan Healthcare Conference, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar competition.

Amgen’s Biosimilars Portfolio Eyes a Share of $65 Billion in Global Sales

Amgen’s chairman and CEO, Bob Bradway, reported that biosimilars will provide an important driver of Amgen’s long-term growth; in addition to launching its adalimumab biosimilar (Amjevita) in the European Union during 2018, and receiving an approval for its bevacizumab biosimilar (Mvasi) last year, Amgen has filed its ABP 980 (trastuzumab) biosimilar for regulatory approval, and is in phase 3 development of ABP 710 (infliximab) and ABP 798 (rituximab) biosimilars.

Amgen is in phase 1 development of an eculizumab biosimilar, and process development of a cetuximab biosimilar, as well as 3 additional molecules. In total, the originator drugs that Amgen’s biosimilars are targeting totaled approximately $65 billion in worldwide sales in 2017, said Bradway.

At the same time, Amgen expects that it will be able to retain a substantial hold on market share for 2 of its originator biologics that face upcoming biosimilar competition. Bradway reported that Amgen’s reference pegfilgrastim (Neulasta) has seen strong success with its Onpro kit, sales of which accounted for 60% of Neulasta sales in the fourth quarter of 2017.

Bradway also noted that Amgen continues to “make strategic investments” in its originator etanercept (Enbrel), which will retain its US patent exclusivity through 2029, despite the approval of a biosimilar, Erelzi.

Mylan: Pegfilgrastim Biosimilar a Potential “Mid-Year 2018 Opportunity”

In a “fireside chat” presentation, Heather Bresch, Mylan’s CEO, and Rajiv Malik, company president, also highlighted progress with biosimilars. Bresch noted Mylan’s 2017 win with the approval of “our Herceptin,” Mylan’s Ogivri.

Bresch, saying that her company has one of the most robust biosimilar pipelines in the industry, did note that the market for biosimilars—as well as for generics like the multiple sclerosis drug glatiramer acetate (Copaxone), which she said was in a similar “bucket” with respect to marketplace challenges—will present a steep industry learning curve as US states address issues of substitution of drugs. Ultimately, she said, “affordability and access is going to drive necessity” for these products.

Malik added that Mylan’s pegfilgrastim biosimilar, which received a complete response letter from the FDA in October 2017, may be a “mid-year 2018 opportunity” for FDA approval. Malik said that “we believe that our mostly scientific issues have bene addressed,” and that the quality issues related to its manufacturing facility have been resolved.

Roche Looks to Combinations for Herceptin, Rituxan

Roche, maker of numerous biologics targeted by biosimilar developers, noted its December 2017 approval of pertuzumab (Perjeta) plus trastuzumab (Herceptin) in HER2-positive early breast cancer, a combination that could help the company to forestall competition from Mylan’s biosimilar trastuzumab when launched.

Additionally, with oncoming biosimilar competition for its reference rituximab, Rituxan, Roche highlighted positive results of studies of its polatuzumab vedotin plus bendamustine versus rituximab plus bendamustine in phase 2 study in treating B-cell malignancies. It also reports that its development program of venetoclax includes venetoclax plus rituximab versus bendamustine plus rituximab in patients with chronic lymphoid leukemia, acute myeloid leukemia, non-Hodgkin lymphoma, and multiple myeloma.

Roche also noted the successful recent launch of its multiple sclerosis drug ocrelizumab (Ocrevus), saying that the therapy has achieved a “broad base of prescribers and a high level of US insurance coverage,” as well as the potential of its atezolizumab (Tecentriq) to achieve new therapeutic combinations by 2020. Tecentriq is currently under investigation for combination with such drugs as bevacizumab (Avastin) for the treatment of non-small cell lung cancer.

Sanofi Eyes Sotagliflozin in the Face of Follow-on Insulin Competition in the Diabetes Market

Olivier Brandicourt, CEO of Sanofi, highlighted the company’s work on sotagliflozin for the treatment of type 1 and type 2 diabetes. Sanofi has faced substantial competition for its insulin products in the United States since Boehringer Ingelheim launched its follow-on insulin glargine (Basaglar), and now finds 2 of its patents for its reference product under review by the US Patent Trial and Appeal Board after a challenge by Mylan.

According to Brandicourt, Sanofi showed steady financial performance despite its decline in diabetes sales (expected to total 6% to 8% for the 2015 to 2018 period), but nevertheless, the company sees sotagliflozin as promising on its positive data showing weight reduction, improved time in range in type 1 diabetes, strong glycated hemoglobin reduction, and reduction in the number postprandial glucose excursions, with no increase in hypoglycemia.