Biosimilars & Generics
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Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?
Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?
Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?
New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.
Supplemental Filings: FDA Can't 'Plug' All Shortage Holes, New Jobs For Billy Dunn, Lisa Parks & Heidi Rebello
From infant formula to drugs, Califf can't get away from shortage work. Plus, the revolving door brings new jobs for some top pharma folks.
Supreme Court Declines ‘Skinny Label’ Case, But Teva To Continue Fight In District Court
Justice Kavanaugh voted to grant Teva’s petition for certiorari. It is unknown if other justices voted with him. The high court last month declined to hear Novartis's Gilenya patent case and Sanofi’s antitrust allegations against Mylan’s EpiPen rebate agreements.
Legal Challenge Could Put UK Drug Pricing Deal At Risk
The body representing generics and biosimilars companies in the UK is seeking a seat at the table as negotiations on a new voluntary price scheme get under way.
Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets
Vanda is fighting FDA’s rejection of jet lag indication for Hetlioz as it faces generic competition for sleep-wake disorder treatment. Federal Circuit finds four Hetlioz patents invalid.
Worries About Innovation Incentives Keep Some Generic, Patent Bills Out of HELP Legislation
In a win for the branded industry, just one of the three amendments that caused the initial markup of the Senate Health Committee’s drug pricing legislation to be postponed got included in the package advanced to the floor.
European Industry Voices Concern As Products Vanish From Market
A fresh report has offered stark new data on the extent to which generics are disappearing from the European market. Industry association Medicines for Europe has pointed to the risks of supply consolidation, urging both national- and EU-level action.
Senate Committee Passes Moderate PBM Reform, But Has Its Eyes On Stronger Policies
Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.
US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them
An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. Pink Sheet charts the approval times and first-cycle clearances over the course of the generic user fee program.
Supplemental Filings: Pink Sheet Notebook On Disease Lobbying, Dan Leonard’s Next Act, And More
Quick takes on Ultragenyx’s CEO lobbing the US FDA for rare disease policy changes, the agency naming a new deputy assistant commissioner for media affairs, the former CEO of AAM starting a consulting firm, and more.
Senate HELP Panel’s Confounded Markup Points To Challenges Ahead For Chairman Sanders
Session on PBM and generic legislation brought to a halt by Republican objections to amendments targeting FDA disclosure of inactive ingredient concentrations in brands, method-of-use patents, and using REMS to extend patent protection.
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