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Generic Drugs Biosimilars European Commission

Goodwin

Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva

Goodwin on

Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and...more

King & Spalding

European Commission Proposal Would Make It Harder for Innovator Companies to Launch Friendly Duplicates (Biosimilars)

King & Spalding on

The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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