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15 December 2015Americas

Apotex ordered to provide 180 days’ biosimilar notice to Amgen

Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.

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More on this story

Amgen dealt blow as FDA rules 'patent dance' optional

30 March 2015 The US Food and Drug Administration has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.

To dance or not to dance: biosimilar strategies post Amgen v Sandoz

3 December 2015 Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.

More on this story

Amgen dealt blow as FDA rules 'patent dance' optional

30 March 2015 The US Food and Drug Administration has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.

To dance or not to dance: biosimilar strategies post Amgen v Sandoz

3 December 2015 Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.

More on this story

Amgen dealt blow as FDA rules 'patent dance' optional

30 March 2015 The US Food and Drug Administration has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.

To dance or not to dance: biosimilar strategies post Amgen v Sandoz

3 December 2015 Following the Federal Circuit’s ruling in Amgen v Sandoz, biosimilar applicants should weigh up several factors when deciding whether to opt into the so-called patent dance. Gerard Norton and Michael Montgomery of Fox Rothschild discuss the potential strategies.

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