Biosimilars & Generics

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.