'Filgrastim-sndz' is Sandoz' Zarxio, the biosimilar of Amgen's Neuprogen
    Following a unanimous approval by a review panel in January, FDA has approved the commercial distribution of the biosimilar form of filgrastim, aka Amgenís Neuprogen. Sandoz' press release, issued on the same day as FDA's, doesn't say anything about a distribution timetable, and a Reuters report says that Amgen is suing to block the sale in the US; a decision on a preliminary injunction is expected in the next couple weeks. That article also puts global filgrastim sales at around $1.2 billion worldwide; Sandoz has been marketing its biosimilar for several years already, as Zarzio. In the US, if the Amgen suit is resolved favorably for Sandoz,
    Analysis from Prime Therapeutics points to severe cost hurdles for biosimilars developed and marketed in the US
    The biosimilars race was supposed to take off after the Biologics Price Competition and Innovation Act was passed (part of the Affordable Care Act) in 2010, but for going on five years now, FDA has only gradually come out with guidances and positions to clear the pathway toward biosimilar approvals. Now, an analysis by Matrix Global Advisors, a Washington consulting firm, and sponsored by Prime Therapeutics, the St. Paul, MN pharmacy benefit manager owned by a dozen Blue Cross/Blue Shield insurers, finds that under the current real-world scenario for researching and then gaining approval for biosimilars, only the biggest of big biologics
    $2-billion acquisition brings a $5-billion/yr PBM to Rite Aid's 4,600 retail stores
    Taking a page from CVS, which acquired the Caremark pharmacy benefit manager (PBM) in 2008, Rite Aid, the No. 3 US retail pharmacy chain, is acquiring EnvisionRx (Twinsburg, OH) in a deal valued at approximately $2 billion. EnvisionRx is being sold by TPG, a private investment firm that had acquired it in July 2013. From Rite Aid's perspective, the transaction is part of the scramble that drug wholesalers, retailers and PBMs are engaged in today. The CVS-Caremark combination was highly controversial at the time, but CVS has succeeded in blending the two types of business, and sees synergies from customers picking up prescriptions at local pharmacies whose cost and reimbursement was arranged by the PBM
    Vaccine trials will continue without a clear path forward
    Daily headlines on the Ebola outbreak in West Africa have subsided, but healthcare needs remain dire, not just for the epidemic but to restore basic healthcare services disrupted by the deadly disease. A Direct Relief flight left Los Angeles International Airport in early February to bring more than $7 million worth of drugs, medical devices and kits, sufficient to support 83 healthcare facilities in Liberia and Sierra Leone. According to Direct Relief, dozens of primary care facilities shuttered during the crisis; malaria and other conditions went untreated; vaccination programs were suspended, prompting a recent measles
    Service eases the management of domestic US shipments to trading partners and patients
    Offering to streamline the cold chain delivery-selection process while providing economies of scale through standardized configurations, UPS Healthcare Logistics is now marketing four packaging lines (Med 100, 200, 300 and 400), each with a range of sizes and options for temperature-controlled duration. The packaging (which is delivered to the shipper) also aligns with UPS' Temperature True service options, which allow for preselected overnight, two-day or other delivery options. "Healthcare customers benefit from more expertise and options created to minimize costs and maximize efficiency
    Company uses online media to promote fill rates by over 50%
    HealthPrize Technologies (Norwalk, CT), one of a handful of companies looking to establish better patient interactions with adherence programs through behavioral economics--i.e., providing rewards for desired behaviors. In practice, the programs use "gamification," turning the serious matters of therapeutic programs, adherence and medical education into a pleasant game where patients are rewarded for taking quizzes, reading downloaded information, or simply logging into a patient education site. HealthPrize has arranged a variety of rewards programs, ranging from online shopping malls to gift cards
    While traditional retail chains still dominate, the focus by PBMs on specialty distribution is raising their presence among top retailers
    Adam Fein, president of Pembroke Consulting (Philadelphia) has previewed his 2014-15 Economic Report on Retail, Mail and Specialty Pharmacies, which includes an estimation of 2014 calendar-year sales by the top retailers. While CVS Health, Walgreen (now Walgreen Boots), Walmart and Rite Aid occupy four of the top five slots (Express Scripts is No. 4), their growth more or less tracked overall industry sales. According to his numbers, Walgreen is now the No. 1 chain retailer, in that CVS health includes both a retail chain
    Compliance issues around sampling will be featured at upcoming conference
    It's not the first, and it won't be the last, but two key organizations in their respective fields--electronic health record (EHR) systems used by doctors' offices, and e-sampling and coupon distribution--are partnering to expand access for sampling and copay or other coupon programs. Practice Fusion (San Francisco), which styles itself as the No. 1 EHR vendor (competing EHR vendors use a variety of measures for this) will now enable the sampling programs managed by OptimizeRx (Rochester, MI) through its SampleMD technology to appear on doctor's screens. Actual numbers of prescribers affected by this are hard to determine
    Express Scripts touts a 'fundamental change' in drug pricing; others would call it negotiating a discount
    Throughout 2014, Gilead Science's Sovaldi treatment for hepC--the first drug that is an outright cure for the disease in many cases--has attracted extraordinary attention. Its high price (about $84K for a 12-week regimen) is not the highest among specialty pharmaceutical therapies; and the cohort of patients--an estimated 3.2 million in the US--is also not extraordinary compared to other debilitating conditions. But the combination of those two factors, its clear advantage over prior therapies and the estimated $8.7 billion it garnered for Gilead through the first 10 months on the market has made it a stalking horse
    Global market will rise 30% over the next five years, reaching $1.3 trillion
    The go-go days of the early 2000s, when the US pharma industry routinely had double-digit growth, haven't exactly returned in full force. But from the 1-3% annual increases in the past several years--including a first-in-recent-history actual decline in 2012--the US market is projected to grow 11-13% when the books close on 2014. The "official" count, from IMS Health, won't be ready until early spring 2015, but in its annual "Global Use of Medicines" report, just issued, IMS' Institute for Healthcare Informatics projects that the US market will be in the range of $377-384 billion for 2014, up 11-13%. It and Japan will experience a "spike" in 2014-5; after that growth
    Regulatory compliance continues to exceed cost as a primary driver
    UPS' seventh global survey of supply chain managers in healthcare products finds a greater consensus of industry goals regarding supply chain management, but a lesser degree of actually following through on those goals. All this is occurring in a context of rapid change, driven by the desire to tap into global markets, adoption of new distribution channels, and the urgency to keep up with expanding regulatory compliance initiatives. "One of the values of this survey is the timeline it establishes for industry issues," notes John Menna, VP for healthcare strategy. "In past years, we've asked about global initiatives and found that 81% of healthcare executives planned
    Pharmaceutical Commerce's latest report finds continued growth in these specialized logistics services
    The 5th edition of the Biopharma Cold Chain Sourcebook analyzes economic, regulatory and technological trends in a vital part of today's industry: the shipment of temperature-controlled products. The just-published report calculates that current (2014) expenditures for commercial shipments will be $8.36 billion, rising to $10.28 billion in 2018. By comparison, last year's Sourcebook estimated the 2013 cold-chain business to be $7.5 billion, rising
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Nearly 100 cargo stations have been enhanced for pharma cold-chain distribution
This fall, Diplomat Pharmacy went public (listed on the NYSE as “DPLO”) and through the end of 2014, saw its stock price rise by around 50%. Pharmaceutical Commerce recently sat down with Diplomat’s CEO, Philip Hagerman. Here’s what he had to say.
Persistent drug shortages are mostly attributable to manufacturing quality problems, but the economics of low-margin generic manufacturing challenge the industry  continued >
When state and federal governments are involved, prices and reimbursements have both regulatory and financial consequences  continued >
In the past five years, the role of Master Data Management (MDM) and informatics has dramatically changed the strategic and operational objectives of life sciences organizations  continued >
Service providers are building out a wider range of services to meet drug developers' needs  continued >
More complex products and higher risk are changing the nature of pharmaceutical outsourcing  continued >
2014 Cold Chain Directory
Our annual compilation of key vendors and service providers in this vital component of pharmaceutical distribution, together with a preview of the IQPC Cold Chain Forum and more late-breaking news
LabCorp’s $6.1-billion bid for leading CRO has implications for pharma’s future
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