The Pharma Data

FEBRUARY 1, 2021

Plegridy is the only approved pegylated interferon for MS with a proven ability to delay the progression of MS disability and reduce relapses. Plegridy was first approved by the FDA in 2014 and is proven to significantly reduce MS relapses, disability progression and brain lesions with a well-understood safety and tolerability profile.

FDA Approval 40

FDA Approval FDA Clinical Trials Biosimilars 40

FDA Law Blog: Biosimilars

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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FDA Regulations FDA Approval Production 59

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

Biosimilars 40

Biosimilars Science FDA Licensing 40

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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FDA Production FDA Approval Compliance 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. In September 2014—nearly ten years ago!—PTE To that end, 35 U.S.C. § 156(c)(4)

FDA Approval 59

FDA Approval FDA Production Therapies 59

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Biosimilars International 52

Agency IQ

JUNE 2, 2023

These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014. Curiously, there is no direction for the patient to seek out the full FDA-approved labeling.

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FDA FDA Approval Production Regulations 40