Pharmaceutical Executive Daily: FDA Approves Ennumo

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI-enabled precision medicine company Scipher Medicine and Teva's global licensing agreement with Polpharma Biologics, and Alina Chesnokova of Cencora examines how the rise of cold chain-dependent specialty therapies is fundamentally changing how pharmaceutical manufacturers think about commercialization strategy and supply chain partnerships.

FDA has approved Ennumo, pegfilgrastim-pccg, as a biosimilar to Neulasta for adults and pediatric patients from newborns onward to decrease the incidence of febrile neutropenia in non-myeloid malignancy patients receiving myelosuppressive chemotherapy, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. The approval makes Accord BioPharma the only company in the United States offering two distinct pegfilgrastim biosimilars alongside its short-acting G-CSF biosimilar Filkri, approved in February 2026, giving the company what it describes as the largest single-company G-CSF biosimilar portfolio in the world and the only lineup capable of addressing both long-acting and short-acting supportive care needs across oncology practices and hospitals.

Two transactions are reshaping the immunology and neurology biosimilar landscape. Chemomab Therapeutics and Scipher Medicine have entered a definitive merger agreement combining Chemomab's first-in-class anti-CCL24 antibody nebokitug with Scipher's AI Network Medicine platform to advance nebokitug through an AI-guided, precision medicine Phase II trial in RA, a disease where the last novel mechanism drug was approved in 2012 and only one-third of patients achieve low disease activity on existing therapies. The combined company is valued at $150 million pre-transaction and will be backed by a $30 million concurrent private placement, with Scipher shareholders holding approximately 68 percent and Chemomab shareholders approximately 32 percent of the combined entity plus contingent value rights tied to nebokitug milestones, with cash runway expected into the second half of 2028.

Separately, Teva Pharmaceuticals International has signed a global licensing agreement with Polpharma Biologics International granting Teva exclusive commercialization rights to Polpharma's proposed biosimilar to Ocrevus in both its intravenous and subcutaneous formulations upon regulatory approval, pairing Polpharma's biosimilar development expertise with Teva's global commercial infrastructure in a deal that positions Teva for the expected wave of MS biologic biosimilar competition as Ocrevus approaches loss of exclusivity in key markets.

Finally, Alina Chesnokova of Cencora discusses the commercialization of advanced and specialty therapies is being fundamentally reshaped by cold chain requirements that demand a rethink of when and how supply chain strategy is built into the launch process. With specialty medicines projected to represent 70 percent of new drug launches through 2027 and roughly half of all products launched globally during that period expected to require cold chain storage. Chesnokova contends that the fragmented, multi-vendor commercialization models that worked for conventional therapies are no longer adequate for biologics, cell and gene therapies, and temperature-sensitive specialty products where a single handling failure can delay patient access entirely.

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