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BioMarin / Amicus Pharmaceutical Merger Phase 1 Investigation

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Published April 1st, 2026
Detected April 1st, 2026
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Summary

The European Commission has accepted notification of a proposed merger between BioMarin Pharmaceutical and Amicus Therapeutics, both pharmaceutical companies engaged in manufacturing, wholesale distribution, R&D, and health activities. The case has been assigned Phase 1 investigation status under the simplified procedure, with a provisional deadline of 17 April 2026 for Commission decision.

What changed

The European Commission formally accepted notification of the BioMarin Pharmaceutical / Amicus Therapeutics merger on 10 March 2026, triggering review under Council Regulation 139/2004. The Commission issued an Art. 4(5) referral decision on 19 February 2026 and an Art. 6(1)(b) decision on 1 April 2026, placing the case in Phase 1 simplified procedure. The transaction involves economic activities in pharmaceutical manufacturing (NACE 21.20), wholesale trade (NACE 46.46), R&D (NACE 72.10), and health services (NACE 86.9).

The case remains ongoing with a provisional decision deadline of 17 April 2026. Both companies should prepare for potential Phase 2 investigation if the Commission identifies competition concerns during initial review. Third parties with relevant information may submit observations to the Commission during this period.

What to do next

  1. Monitor EC case tracker for updates on Phase 1 decision by 17 April 2026
  2. Prepare preliminary assessment of competitive overlap if required by Commission remedy requests
  3. Consider notifying national competition authorities in member states where operations overlap

Source document (simplified)

M.12314

Merger Ongoing Simplified Subscribe for updates

BIOMARIN PHARMACEUTICAL / AMICUS THERAPEUTICS

Companies: BIOMARIN PHARMACEUTICAL | AMICUS THERAPEUTICS Last decision date: 01.04.2026 Case type: Merger Investigation phase: 1 Regulation: Council Regulation 139/2004 Notification date: 10.03.2026 Provisional deadline: 17.04.2026 Economic activities: C.21.20 - Manufacture of pharmaceutical preparations (NACE Rev. 2.1) G.46.46 - Wholesale of pharmaceutical and medical goods (NACE Rev. 2.1) N.72.10 - Research and experimental development on natural sciences and engineering (NACE Rev. 2.1) R.86.9 - Other human health activities (NACE Rev. 2.1) Decisions Art. 6(1)(b) of 01.04.2026 Art. 4(5) - Referral of 19.02.2026 Other case related information Publication in the OJ: OJEU C/2026/1745 of 17.03.2026 Description of the concentration of 11.03.2026: EN published on 12.03.2026

Named provisions

Article 6(1)(b) Decision Article 4(5) Referral Simplified Procedure

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
EC DG COMP
Published
April 1st, 2026
Compliance deadline
April 17th, 2026 (15 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
Case M.12314 / OJEU C/2026/1745
Docket
M.12314

Who this affects

Applies to
Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Merger Control Pharmaceutical Manufacturing Pharmaceutical Wholesale
Geographic scope
European Union EU

Taxonomy

Primary area
Antitrust & Competition
Operational domain
Compliance
Compliance frameworks
Dodd-Frank
Topics
Pharmaceuticals Merger Control

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