Weekly Pharma Manufacturing News Roundup — September 23, 2014

CPhl Panel Calls For “Radical Shift” In Pharma

Three experts in part one of CPhl’s second annual report have voiced their expectations for the industry and have come out in favor of several “radical changes” that will help spur innovation and reduce pharma manufacturing costs. Among these proposed changes include the call to reduce “onerous” IPR requirements in developing economies in order to encourage innovation and ensure savings and profit increases. However, a differing argument also highlighted in the report is that Quality by Design (QbD) must be a primary part of the manufacturing and development process that is integrated into the process from concept to commercialization. In implementing QbD throughout the entire development process, the industry would become more efficient, improve product quality, and lower costs so pharma could sell to more populations around the world. 

Canadian Pharma Manufacturing Industry Hit By Patent Losses

A new IBISWorld and Canada Industry Market Research report highlights the state of brand name Canadian pharmaceutical manufacturing. According to the report, the industry is forecasted to decline at a 2.4 percent annualized rate, reaching $16.7 billion through 2014. The loss of patent protection on brand name drugs has been responsible for costing the industry $1.8 and $2.5 billion in 2010 and 2012 respectively. As drugs lose patent protection, drug manufacturers have begun streamlining their operations by partnering with public or private companies and academic institutions, leading to shared R&D costs. Private health insurance providers have also played a role in the loss of revenue by turning to generics in order to cut healthcare costs. However, as 2014 comes to a close, revenue will begin to rise again at a rate of 0.4 percent as biologics and specialty drugs bolster pipelines.

Branded Diabetes Therapies Driving T2D Market To $47B

Decision Resources Group has found that the type 2 diabetes (T2D) market is set to accelerate in value from $26 billion in 2013 to $47 billion in 2023. Some popular players in the market include the following classes of drugs: SGLT-2 inhibitors, GLP-1 receptor agonists, and biosimilar insulins. Similarly, it is becoming common that, as cost burden increases for T2D, payer and reimbursement agencies are restricting the drug options physicians can prescribe — especially the classes that have multiple therapy options, including DPPV-IV inhibitors.

UAE Gaining New Cancer Drug, Vaccine Manufacturing Center

The Arabian Times reports that 2016 will be the year the UAE begins manufacturing cancer drugs. The new Khalifa Industrial Zone Abu Dhabi (Kizad) plant comes with a price tag of $160 million, and it will be the first facility in Kizad to manufacture pharmaceutical products. There will be four production facilities housed in the new center, including a cancer control and research facility, and facilities to manufacture vaccines, sterile injections, and oral solid dosage for diseases, including hepatitis and influenza. The cancer facility will be the first branch to be operational in early 2016. A recent report from Alpen Capital revealed that the UAE is likely to maintain its silver medal standing as the second largest pharma market.

Bio/Pharma Spending On Contract Pharma Increasing

The Contract Services industry has been the recipient of increased funding from global biopharma and pharma companies. Of those bio/pharma companies that took part in the PharmSource — Pharmaceutical Technology Outsourcing Survey, 19 percent said their spending on contract services had risen by at least 20 percent from 2013. According to 23 percent of contract service providers, small bio and pharma companies were identified as the best-performing customer segment in the contract services business, as smaller companies are seeing improved VC and partnering funding. The report does warn however, that CMOs and CDMOs need to be aware that the contract services industry is benefitting from this contracting uptick because of an improved financial environment, rather than increased acceptance of outsourcing.

The Impact Of FDA Regulations On Pharma Manufacturing

A recent article from Ferret, Australia's Manufacturing, Industrial, and Mining Directory, examines the impact that the latest FDA update of CFR21/11 to 21 part 11 of the Code of Federal Regulations will have on the pharmaceutical manufacturing sector. Since the initiation of this Code, manufacturers abroad and in the U.S. have had to improve automated procedures, leading to discussions about electronic records, signatures, time stamps, maintenance of electronic records, and traceability. In particular, the article examines the impact of the audit trail and the use of a risk-based approach in order to be in compliance with the Code.

EuropaBio Releases Opinion On Biosimilar Labelling

Adding to the score of opinions in the recent hot-button issue of biosimilar labeling, EuropaBio released a statement recently voicing the opinion of the healthcare biotechnology industry. The healthcare council is arguing for a transparent label that provides information for both the biosimilar and reference product so patients and physicians are more informed in their treatment selections.  

Pharma Talking Points

An article on Supply Management discusses a recent presentation given by Vincent Dunne, Shire Pharmaceutical’s head of supply chain. In his speech, Dunne argues that products such as Apple Watch and Google glass — both of which offer sensors and health apps — will be a key influence on the life sciences supply chain.

In a recent Q&A on Packaging Digest, Bob Celeste, senior director of healthcare, GS1 U.S., provides some insights into the current status of DSCSA and traceability.

The Wall Street Journal reports that a potential Supreme Court case might affect the way generic-drug makers label products. The primary issue at hand is how quickly generic manufacturers need to change labels in order to match the changes being made in brand-name meds. Originally, the Supreme Court ruled generic manufacturers were not permitted to add additional information to labels unless the branded drug maker has done so first, meaning the generic makers would not be responsible for failure to notify patients of any risks. However, this new case could stand to shift responsibility to the generic manufacturers to change the labels once a risk is known, even if the branded drug maker has not.