- FDA approvals for specialty drugs to pick up in 2017 (managedhealthcareexecutive.modernmedicine.com)
The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars...Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017... Last year we saw a dip in...approvals but this year we are going to rebound with about 30 pending approvals...With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years...New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market...Biologics are really acting more like competing brands, coming in at perhaps a 15% discount" compared to brand-name biologics...
- Pending approvals/patent expirations
- Recently approved specialty medications
- Specialty drug pipeline
- Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds: report
There’s no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. But they’ve also helped mass-market drugmakers rack up millions in incentives, tax breaks and patent-protected profits—in some cases through monopoly pricing...About one-third of the orphan drug approvals the FDA doled out since the program began more than 30 years ago have been for repurposed, large-market products or drugs with multiple orphan green lights...Best-sellers such as Crestor…,Abilify…,Herceptin…,and Humira...fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations...What we are seeing is a system that was created with good intent being hijacked…Repurposing a drug isn’t necessarily a bad thing, of course, if it can help get a treatment to additional patients...But when the orphan incentives allow competition-free drugmakers to charge whatever prices they want for their meds?...Now...it seems like...this practice may be driving up prices...Industry lobby groups...are unsurprisingly in favor of maintaining the status quo. With rare diseases “tragically killing and brutalizing mostly children,” incentives for orphan drugmakers should be kept in place...the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar...