The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from May 11, 2026 – May 21, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance
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CHMP Adopts Positive Opinion for Ranibizumab Biosimilars VISLYFA and REXATILUX
Eli Lilly Expands Vaccine Portfolio by Acquiring Three Developers
Client Alert on the SEC’s Proposed Changes to the Registered Offering Framework
We published on our client alert on the SEC’s proposed amendments to the Securities Act registration framework that are intended to modernize and streamline the registered offering process. Highlights include:
- SEC proposes significant amendments to modernize and streamline the registered
FDA Approves Shanghai Henlius Biotech IND for Cetuximab Biosimilar
On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United
FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks a Preliminary Injunction to Block Their Launch
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI
SEC Proposes to Simplify Filer Status for Public Companies
On May 19, 2026, the SEC proposed amendments to its rules and forms that would simplify the filer status determinations for public companies and expand the disclosure accommodations available for many public companies. Under the proposed amendments, the threshold for
SEC Proposes Sweeping Changes to the Registered Offering Framework
The SEC today proposed amendments that would represent a sweeping overhaul of the registered offering framework if adopted. The proposed amendments would significantly expand access to Form S-3 and shelf registration, extending many benefits currently limited to well-known seasoned issuers
International Biosimilars Updates
On April 21, 2026, Biocon announced that Health Canada granted a Notice of Compliance (NOC) for BOSAYATM (denosumab) and VEVZUOTM (denosumab), biosimilars of Amgen’s Prolia® (denosumab) and Xgeva® (denosumab).
Denosumab is a human monoclonal antibody that targets and binds to