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October 2017

Vol. 34
No. 10


Full Issue of Generic Line in PDF Format

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New International Deal Lowers Price of Generic HIV Regimen to $75 Per Year

A new pricing agreement will allow a leading HIV regimen to be rolled out in more than 90 low- to middle-income countries, at an average cost of $75 per patient, per year. Read More

New MAPP Outlines Internal ANDA Verification Checklist for FDA Reviewers

The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a formal evaluation. Read More

Pfizer Sues J&J Over ‘Exclusionary Contracts’ to Block Biosimilar Infliximab

Pfizer is suing Johnson & Johnson over its contracts and rebate policies with insurers and hospitals, saying they are designed to block sales of a biosimilar for J&J’s blockbuster Remicade therapy. Read More

FDA Working to Bring Puerto Rican Drug Manufacturing Back Online

Following the destruction brought by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More

FDA’s ANDA Approval Rate Slows as Fiscal Year Nears End

The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing the previous three months. Read More

Let Drugmakers Create Their Own REMS to Foster Generics, Says CVS

To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Read More

FDA Guidance Outlines Statistical Concerns for Proving Biosimilarity

Biosimilar sponsors should take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s effort to lower drug prices. Read More

FDA Approves First Cancer Biosimilar: Amgen’s Mvasi

The FDA approved the first U.S. biosimilar for the treatment of cancer, Amgen’s Mvasi, a biosimilar of the blockbuster Avastin. Read More

ICH Finalizes Q&A Doc on Justifying Drug Starting Materials

The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More

FDA Issues PAS and DMF Guidances as GDUFA II Gets Underway

Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Read More

FDA Guidance Steps Up Push to Speed Generics to Market

As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from ANDA sponsors seeking earlier meetings to smooth out the review process. Read More

Judge Dismisses Price-Fixing Claims Against Generic Drugmakers

A Pennsylvania federal judge dismissed a class-action lawsuit against more than 10 drugmakers that accused them of misrepresenting facts to inflate generic drug prices. Read More

DOJ Sides With Sandoz in SCOTUS Case Leftovers Against Amgen

The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should preempt state laws on the topic. Read More

FDA Goes Too Far in GDUFA II Draft Guidance, AAM Says

An FDA policy proposal on expedited generic drug approvals runs counter to the goals of the program and breaks faith with the upcoming GDUFA II agreement with the industry, generic drugmakers said. Read More

Invidior Plans to Appeal Verdict in Suboxone Patent Case

Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More

Court Rejects AbbVie Patent Suits, Boosting FTC Pay-for-Delay Claims

A federal judge in Pennsylvania threw out AbbVie’s patent suits against generic competitors, strengthening the Federal Trade Commission’s pay-for-delay case against the drugmaker. Read More

PTAB Invalidates Aventis Patent Following Mylan Challenge

The PTO’s Patent Trial and Appeals Board invalidated Aventis Pharma’s patent for the chemotherapy drug Jevtana (cabazitaxel), following a challenge from Mylan. Read More

AIDS Groups Call on New York AG to Investigate Pay-For-Delay by Gilead

Two AIDS patient advocacy groups urged New York Attorney General Eric Schneiderman — a frequent foe of anticompetitive behavior by drugmakers — to investigate potential pay-for-delay deals by Gilead. Read More