- WHO to help bring cheap biosimilar cancer drugs to poor (reuters.com)
The World Health Organization is to launch a pilot project this year to assess cheap copies of expensive biotech cancer drugs in a bid to make such medicines more widely available in poorer countries...The U.N. agency said...it would invite drugmakers in September to submit applications for pre-qualification of so-called biosimilar versions of two such drugs on its essential medicines list, Roche's Rituxan (rituximab) and Herceptin (trastuzumab)...The move is a boost for biosimilars which are expected to account for a growing proportion of treatments, particularly for cancer, as patents on the original branded products expire...The WHO plays a critical role in monitoring drug quality in poorer countries through its pre-qualification program, which ensures that treatments supplied by U.N. agencies such as UNICEF are of acceptable quality...
- Lawyers for Roche, Biocon trade contempt charges in Herceptin biosim case (fiercepharma.com)
A long-running court case filed in India by Roche seeking to prevent the use of label language by...Biocon and Mylan from claiming similarity to its aging breast cancer med Herceptin (trastuzumab) has turned tense--with both sides now seeking contempt-of-court charges...In the case of Roche...Biocon "violated a previous court order" temporarily barring any claims to similarity by using such language in a presentation at an international scientific conference on clinical trials with trastuzumab...At the same time, Biocon accused Roche of "disparaging statements" about the company as part of a campaign to block approval efforts for a trastuzumab biosimilar by Biocon in other countries...noting that Phase III trials are underway in the U.S. for a version of the breast cancer therapy...At the heart of the case is...that Biocon and...Mylan could not use the label biosimilar for versions of Roche's med.
- 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
- China’s High Cancer Drug Prices Create a Lucrative Market in Hong Kong (bloomberg.com)
..Hong Kong’s Nathan Road is a favorite destination for tourists from the mainland…Small, rainbow-lit drugstores have become a feature of some of Hong Kong’s most expensive neighborhoods…Their lineups include muscle rubs, painkillers, aphrodisiacs, and traditional Chinese medicines...if you ask discreetly, some will also sell you something else: cancer and hepatitis C drugs...Visitors from the mainland also prefer to buy their medicine in Hong Kong because they believe it’s less likely to be counterfeit…Cancer rates in China are soaring…Most Chinese lack prescription drug benefits and must pay out of pocket for premium medicines. The upshot: Prices for treatments from foreign drugmakers are some of the highest in the world…90 percent of cancer drug sales at pharmacies are to mainland tourists...
- 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...