Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for HLX11 (U.S. trade name: POHERDY), a biosimilar to Roche’s Perjeta (pertuzumab). The recommendation covers all EU‑approved indications for the reference product, including HER2‑positive early and metastatic breast cancer.
Regulatory Milestone
Item
Detail
Company
Shanghai Henlius Biotech, Inc. (HKG: 2696)
Product
HLX11 (POHERDY in U.S.)
Reference Product
Roche’s Perjeta (pertuzumab)
Drug Class
HER2‑targeted biosimilar monoclonal antibody
Regulatory Body
EMA CHMP (positive opinion); EC (final decision pending)
Indications
All EU‑approved Perjeta indications: HER2+ early and metastatic breast cancer
Prior Approvals
US approved (interchangeable biosimilar designation); Canada MAA under review
Approved Indications (Proposed)
Setting
Combination
Patient Population
Neoadjuvant
HLX11 + trastuzumab + chemotherapy
HER2+ locally advanced, inflammatory, or early‑stage breast cancer at high recurrence risk
Adjuvant
HLX11 + trastuzumab + chemotherapy
HER2+ early breast cancer at high recurrence risk
Metastatic
HLX11 + trastuzumab + docetaxel
HER2+ metastatic or locally recurrent unresectable breast cancer (no prior anti‑HER2 or chemo for metastatic disease)
Biosimilar Evidence
Assessment
Finding
Analytical Similarity
Comprehensive studies demonstrate structural and functional equivalence
Clinical Comparability
Comparative studies confirm similar quality, safety, and efficacy vs. reference product
CHMP Basis
Review of analytical + clinical data supporting biosimilarity
Strategic Implications
HER2+ Breast Cancer Access: Perjeta‑based regimens are standard‑of‑care for HER2+ breast cancer; HLX11 biosimilar entry will reduce treatment costs and expand patient access across Europe.
Global Biosimilar Portfolio: HLX11 joins Henlius’ serplulimab (PD‑1) and other biosimilars, establishing the company as a leading China‑based biologics developer with US, EU, and Canada regulatory traction.
Interchangeability Validation:US interchangeable designation (first for a pertuzumab biosimilar) supports pharmacy‑level substitution and payer confidence; EU approval would reinforce global commercial viability.
Roche Competition: HLX11 entry will pressure Perjeta pricing (~ $4 billion annual global sales); Henlius’ cost‑competitive manufacturing provides margin advantage in tender‑driven European markets.
Market Context
Factor
Impact
HER2+ Breast Cancer Incidence
~ 300,000+ annual cases in EU; pertuzumab‑based therapy in ~ 60% of eligible patients
Biosimilar Uptake Drivers
Automatic substitution policies in multiple EU states; oncology biosimilar experience supports rapid adoption
Henlius Commercial Strategy
Partnership with Sandoz for EU commercialization (per prior agreements) leverages established oncology market access
Global Expansion
US approval + EU CHMP opinion + Canada review positions HLX11 for trilateral market entry in 2026
Forward‑Looking Statements This brief contains forward‑looking statements regarding EC final approval, commercial launch timelines, and market share capture in EU HER2+ breast cancer market. Actual results may differ due to risks including originator pricing responses, automatic substitution policy variations, and manufacturing supply consistency.-Fineline Info & Tech
By Fineline Cube