Last reviewed 2026-04-23 · How we verify

MYL-1701P

Mylan Pharmaceuticals Inc · Phase 3 active Small molecule

MYL-1701P is a G-CSF receptor agonist (pegylated biosimilar) Small molecule drug developed by Mylan Pharmaceuticals Inc. It is currently in Phase 3 development for Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.

MYL-1701P is a biosimilar of pegfilgrastim that stimulates neutrophil production to prevent chemotherapy-induced neutropenia.

MYL-1701P is a biosimilar of pegfilgrastim that stimulates neutrophil production to prevent chemotherapy-induced neutropenia. Used for Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MYL-1701P
Sponsor	Mylan Pharmaceuticals Inc
Drug class	G-CSF receptor agonist (pegylated biosimilar)
Target	G-CSF receptor (GCSFR)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

MYL-1701P is a pegylated granulocyte colony-stimulating factor (G-CSF) analog that binds to G-CSF receptors on hematopoietic progenitor cells, promoting their proliferation and differentiation into neutrophils. By increasing circulating neutrophil counts, it reduces the duration and severity of chemotherapy-induced neutropenia, thereby decreasing infection risk in cancer patients receiving myelosuppressive chemotherapy.

Approved indications

Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy

Common side effects

Bone pain
Injection site reactions
Headache
Fatigue
Splenomegaly

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MYL-1701P CI brief — competitive landscape report
MYL-1701P updates RSS · CI watch RSS
Mylan Pharmaceuticals Inc portfolio CI

Frequently asked questions about MYL-1701P

What is MYL-1701P?

MYL-1701P is a G-CSF receptor agonist (pegylated biosimilar) drug developed by Mylan Pharmaceuticals Inc, indicated for Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.

How does MYL-1701P work?

MYL-1701P is a biosimilar of pegfilgrastim that stimulates neutrophil production to prevent chemotherapy-induced neutropenia.

What is MYL-1701P used for?

MYL-1701P is indicated for Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.

Who makes MYL-1701P?

MYL-1701P is developed by Mylan Pharmaceuticals Inc (see full Mylan Pharmaceuticals Inc pipeline at /company/mylan-pharmaceuticals-inc).

What drug class is MYL-1701P in?

MYL-1701P belongs to the G-CSF receptor agonist (pegylated biosimilar) class. See all G-CSF receptor agonist (pegylated biosimilar) drugs at /class/g-csf-receptor-agonist-pegylated-biosimilar.

What development phase is MYL-1701P in?

MYL-1701P is in Phase 3.

What are the side effects of MYL-1701P?

Common side effects of MYL-1701P include Bone pain, Injection site reactions, Headache, Fatigue, Splenomegaly.

What does MYL-1701P target?

MYL-1701P targets G-CSF receptor (GCSFR) and is a G-CSF receptor agonist (pegylated biosimilar).

Drug class: All G-CSF receptor agonist (pegylated biosimilar) drugs
Target: All drugs targeting G-CSF receptor (GCSFR)
Manufacturer: Mylan Pharmaceuticals Inc — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Chemotherapy-induced neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing