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Biosimilars & Generics

Set Alert for Biosimilars & Generics

MPP Strikes Long-Acting Injectable Cabotegravir Deal For HIV PrEP

After the Medicines Patent Pool secured a licensing deal with ViiV Healthcare for long-acting injectable cabotegravir for HIV pre-exposure prophylaxis, prospective generic sub-licensees have until 4 September to submit expressions of interest.

Deals Intellectual Property

Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Approvals Biosimilars

UK CMA Issues £70m Fines To Pfizer And Flynn Over Phenytoin

After reassessing part of a UK case involving Pfizer and Flynn Pharma over pricing for phenytoin sodium capsules, the country’s competition regulator has reaffirmed that the companies abused their dominant positions to overcharge the NHS and has issued £70m in fines.

Legal Issues Pricing Strategies

Teva Wins Support For Nationwide Opioid Settlement With Bigger Cash Offer

Teva to pay $4.25bn over 13 years under agreement in principle with 12 state attorneys general, Native American tribes and plaintiffs’ lawyers. Previous settlement offer provided mostly medication. Deal is contingent on governments signing on and Allergan inking settlement.

Legal Issues Generic Drugs

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

Generic Drugs Drug Review

For ANDAs, Pre-Submission Facility Correspondence Has Improved, But Still Not Ideal

US FDA wants the program, intended to help speed ANDA approvals, utilized more, but industry still questions the information that must be submitted.

Generic Drugs Review Pathway

Top EU Court Urged To Take Harder Line On Servier Perindopril Agreements

European allegations of abuses of dominant positions in the pharmaceutical sector may once again be reframed, after the CJEU was advised by advocate general Juliane Kokott to set aside certain findings of the General Court on settlement deals made by Servier with multiple generics firms over perindopril.

Legal Issues Europe

Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard

After Federal Circuit vacates district court ruling that patent on method of dosing ImmunoGen’s mirvetuximab soravtansine is indefinite and obvious, PTO warns of ‘well-documented problem’ of drug manufacturers receiving follow-on patents for ‘trivial modifications’ that delay generics.

Intellectual Property Legal Issues

FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy

The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.

Intellectual Property Generic Drugs

HHS Price Negotiations Could Be Delayed When Biologics Have Biosimilars Pending Under Bill

Latest iteration of drug pricing legislation from Senate Democrats would also firm up the number of drugs HHS must choose for price negotiation each year and no longer treats insulin as a separate class for purposes of negotiation.

Pricing Debate Medicare

Access In Jeopardy If Generics Excluded From EU Centralized Procedure

Recent suggestions by the European Commission’s Pharmaceutical Committee that generics could be excluded from the centralized procedure for marketing authorizations would create barriers to access and put extra pressure on the European regulatory network overall, Medicines for Europe believes. The association has urged the authorities to abandon the idea.

Regulation Europe

Confusion Persists Over US Biosimilar Interchangeability

The US biosimilars industry is being constrained by misunderstandings stemming from the country’s interchangeability designation, a new paper in BioDrugs has highlighted, citing an urgent need for clarity over the misperception that interchangeable biosimilars are superior to biosimilars without the designation.

Biosimilars Review Pathway
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