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India's Intas Has Just Won the Largest G-CSF Biosimilar Portfolio in the World — Accord BioPharma's ENNUMO FDA Approval Makes It the Only Company With Two Distinct Pegfilgrastim Biosimilars

By Mustafa Shariff, Editor in Cheif · July 23,2026 · 2 min read

Summary

• Accord BioPharma's ENNUMO FDA Approval: Intas Pharmaceuticals Claims World's Largest G-CSF Biosimilar Portfolio With Two Distinct Pegfilgrastim Options
• Accord BioPharma, the US arm of India's Intas Pharmaceuticals, received FDA approval for ENNUMO (pegfilgrastim-pccg) on July 9, 2026, giving it the largest G-CSF biosimilar portfolio in the world from a single company.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies. With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings."

Accord BioPharma, the US specialty biosimilar division of Ahmedabad-based Intas Pharmaceuticals Limited — one of India's largest and most globally active pharmaceutical companies — announced on July 9, 2026 that the US Food and Drug Administration has approved ENNUMO (pegfilgrastim-pccg) as a biosimilar to Amgen's Neulasta (pegfilgrastim). The approval makes ENNUMO the eighth pegfilgrastim biosimilar approved in the US, and with it, Accord BioPharma becomes the only company in the United States currently marketing two distinct pegfilgrastim biosimilar products.
ENNUMO joins Accord BioPharma's existing oncology supportive care portfolio: UDENYCA (pegfilgrastim-cbqv), its first long-acting pegfilgrastim biosimilar, and FILKRI (filgrastim-laha), its short-acting granulocyte colony-stimulating factor biosimilar approved in February 2026. Together, these three products form what Chrys Kokino, President of Accord North America, describes as the largest G-CSF biosimilar portfolio in the world from a single biosimilar company.
What G-CSF Does and Why It Matters for Oncology
Granulocyte colony-stimulating factors (G-CSFs) are biological therapies that stimulate the bone marrow to produce neutrophils — white blood cells that are a critical component of the immune system's defence against bacterial infection. Myelosuppressive chemotherapy — the class of cancer treatments that includes cyclophosphamide, docetaxel, doxorubicin, and many other commonly used agents — suppresses bone marrow function, causing neutrophil counts to drop dramatically. Low neutrophil counts (neutropenia) leave patients vulnerable to serious bacterial infections, including the life-threatening emergency of febrile neutropenia (fever with neutropenia), which can require hospitalisation and IV antibiotics and in severe cases can be fatal.
Pegfilgrastim (Neulasta) is a long-acting form of G-CSF (filgrastim conjugated with polyethylene glycol to extend its half-life) designed to be administered once per chemotherapy cycle rather than daily. It has become the standard-of-care prophylaxis for febrile neutropenia in patients receiving myelosuppressive chemotherapy regimens where febrile neutropenia risk exceeds 20%.
ENNUMO carries the same approved indications as Neulasta: reducing the incidence of infection manifested as febrile neutropenia in adults and children receiving myelosuppressive chemotherapy for non-myeloid cancers, and improving survival in patients accidentally exposed to myelosuppressive doses of radiation associated with Hematopoietic Subsyndrome of Acute Radiation Syndrome.
The India Connection: Intas Pharmaceuticals' Biosimilar Journey
Accord BioPharma's G-CSF portfolio is the US-market expression of Intas Pharmaceuticals' broader commitment to becoming a global biosimilar leader backed by Indian pharmaceutical manufacturing capability. Intas is one of the world's most experienced biosimilar developers by programme count, with a pipeline spanning oncology (G-CSF, monoclonal antibodies), immunology (TNF inhibitors), and central nervous system therapies. The company's biosimilar development capability connects to the same manufacturing excellence that has driven India's global pharmaceutical reputation over the past three decades.
The ENNUMO approval specifically leverages technology transferred from South Korea's SunBio, which supplies the high-quality polyethylene glycol derivative essential to pegfilgrastim manufacturing — a detail that illustrates the international supply chain partnerships that underpin even 'Indian' biosimilar products. The complex biology of large-molecule biosimilars requires inputs across multiple geographies and technology platforms, and India's biosimilar companies have built the international partnerships necessary to access these inputs.
Accord BioPharma's target of 20 US biosimilar launches by 2030 — across oncology, immunology, and CNS — represents the commercial ambition of a company that views the US biosimilar market as a multi-decade growth opportunity. Each approval is both a commercial milestone and a validation of Intas's global biosimilar manufacturing and regulatory capability.
The Febrile Neutropenia and G-CSF Market Context
Febrile neutropenia remains one of the most serious complications associated with myelosuppressive chemotherapy — creating treatment delays, dose reductions, hospitalisations, and increased mortality risk. BHC Media covered the US ifosfamide shortage in our July 7 edition as an example of what happens when a critical oncology supportive care therapy is unavailable. G-CSF therapies like ENNUMO are in the adjacent supportive care category — not treating the cancer directly, but protecting patients' immune systems during the chemotherapy that treats it. The two products address different chemotherapy complications (ifosfamide treats the cancer; G-CSF prevents the neutropenia that ifosfamide and other myelosuppressive agents cause).
BHC Perspective
At Bengaluru Health Community, Accord BioPharma's ENNUMO approval is a biosimilar success story built on Indian pharmaceutical capability and managed through a US commercial platform. Intas Pharmaceuticals represents the Indian pharmaceutical company that has most systematically built a global biosimilar business — not just manufacturing biosimilars for others, but commercialising them through its own US division to capture the full commercial value chain. For BHC founders in biosimilar development, biologics manufacturing, or oncology supportive care — the Accord BioPharma model is the blueprint for how Indian biosimilar companies capture global commercial value.
Frequently Asked Questions
Q: What did Accord BioPharma receive?
A: FDA approval for ENNUMO (pegfilgrastim-pccg), a long-acting G-CSF biosimilar to Amgen's Neulasta, on July 9, 2026. ENNUMO is the eighth US pegfilgrastim biosimilar, and makes Accord BioPharma the only US company with two distinct pegfilgrastim biosimilars (ENNUMO + UDENYCA) alongside a short-acting filgrastim biosimilar (FILKRI).
Q: What is pegfilgrastim used for?
A: A long-acting G-CSF (granulocyte colony-stimulating factor) given once per chemotherapy cycle to reduce febrile neutropenia risk — a life-threatening immune complication of myelosuppressive chemotherapy. Standard of care for patients receiving regimens with >20% febrile neutropenia risk.
Q: Who is behind Accord BioPharma?
A: Accord BioPharma is the US specialty division of Ahmedabad-based Intas Pharmaceuticals Limited, one of India's largest and most globally active pharmaceutical companies. ENNUMO's manufacturing leverages technology from South Korea's SunBio for the PEG component. Accord BioPharma targets 20 US biosimilar launches by 2030 across oncology, immunology, and CNS.