Biosimilar Manufacturer Reliability Is Key To Market Uptake, Amgen Says

In its latest biosimilar trends report, Amgen makes the case for purchasing biosimilars from a company with a track record for quality biologics manufacturing – presumably, one such as its own.

Biosimilar manufacturers' known or expected ability to reliably supply their products will be one of many factors expected to drive formulary and prescribing decisions in the nascent market, a new Amgen Inc. report states.

While manufacturing reliability and drug shortages have been a key concern for small molecule injectable drugs in recent years, the report suggests that such concerns also could undermine market penetration of products approved under the 351(k) pathway.

The "2016 Trends In Biosimilars Report" marks Amgen's third report on the subject. The company said it is intended to give stakeholders a guide to the latest topics, trends, and issues pertinent to the US introduction and adoption of such products. The report includes insights from an editorial council comprising medical and pharmacy directors from managed care organizations and employer and benefit design consultants.

Among the topics covered are FDA regulatory issues related to product approval, naming and interchangeability, Centers for Medicare and Medicaid Services coding and payment policies, private payer coverage, provider and patient education, and pharmacovigilance.

Go With Someone You Know

The report does not cast aspersions on any particular manufacturer or developer in the biosimilar space, an arena that ranges from small biotechs without any approved products on the US market to traditional small molecule generic companies and major biopharma companies.

However, the paper can be viewed as making the case for purchasing biosimilars from well-established companies with a longstanding reputation for quality biologics manufacturing – presumably, a category into which Amgen falls.

The biotech giant's products have been the target of some of the earliest biosimilar application submissions, including Sandoz Inc.'s Zarxio (filgrastim-sndz), the first product approved under the 351(k) pathway and a biosimilar to Amgen's Neupogen (filgrastim).

However, Amgen is on the verge of making waves with its own biosimilar entry. Its first 351(k) application, referencing AbbVie Inc.'s blockbuster TNF-inhibitor Humira (adalimumab), is pending at FDA with a Sept. 25 user fee goal date (Also see "From Hunted To Hunter: Amgen Seeks Approval of Biosimilar To Humira" - Pink Sheet, 25 Nov, 2015.)

The website for Amgen Biosimilars says the company "is well positioned to leverage its more than 30 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide."

Critics may view the Amgen report as an effort to boost its own standing – and raise doubts about other manufacturers in the process – as it seeks to establish its foothold in the biosimilar market.

However, the report raises an important concern, particularly for some of the early biosimilars on the US market. If payers and health care providers go to great lengths to adopt the new products and favor them over reference products, they may lose faith in the market if the product supply is not reliable.

Lessons From Small Molecule Injectables

Drug shortages can have significant fiscal impacts on health care providers and clinical impacts on individual patients' treatment, the report says.

"Concerns about reliability of supply are well-founded based on the generic manufacturing industry's history with the production of sterile injectables, which is a segment of the pharmaceutical market that has suffered numerous shortages over the years – largely due to quality control issues," the report states.

It cites a 2014 Government Accountability Office report that found quality problems accounted for 40% of the drug shortages from 2011-2013 (Also see "Drug Shortage Analysis Puts FDA At Loggerheads With GAO" - Pink Sheet, 10 Feb, 2014.).

The trends report also points to an analysis suggesting that inadequate reimbursement for multisource drugs primarily covered by Medicare may be another reason for the shortage of certain injectables in the small molecule generics market. This is "a risk factor that also might apply in the future for certain classes of biosimilar products," the report states.

"As more manufacturers plan to enter the biosimilar market, it will likely become increasingly important for stakeholders to have an understanding of each company's manufacturing capabilities, quality assurance process, reputation for consistent supply, and plans for avoiding shortages," the report states.

Pharmacy and therapeutics (P&T) committees responsible for making formulary decisions may consider a biosimilar manufacturer's reliability, safety and quality control history, as well as safeguards to ensure manufacturing capacity and dependability, the report states.

"It may also be important to evaluate a manufacturers' ability to institute procedures to ensure a steady product supply, including backup or multisite manufacturing capabilities to accommodate unexpected disruptions at the primary manufacturing site."

Biosimilar Formulary Tier

Manufacturing reliability is one of several factors expected to inform coverage and preference decisions for biologics and biosimilars.

Among the other "game changer" factors cited in the report are coverage policies, logistical considerations for inventory and data management systems, safety, patient and provider education, and reimbursement.

In the category of coverage policies, the report suggests that biosimilars might not fit cleanly into existing formularies that consist of tiers for generic, preferred brands, non-preferred brands and specialty drugs.

Consequently, "questions may arise as to whether or not to place biosimilars on a currently existing tier, or to create a new tier for a specialty drug that is also a biosimilar," the report states.

The consulting firm Avalere Health has suggested creation of a biosimilar-specific formulary tier as a potential fix to the current disincentive for biosimilars in the Medicare Part D coverage gap (Also see "Biosimilars Pricing In Medicare Part D Needs Legislative Fix, Avalere Says" - Pink Sheet, 12 Apr, 2016.).

Under CMS rules and guidance, biosimilars are not subject to the 50% manufacturer discount required when beneficiaries reach the coverage gap. The Amgen report similarly recognizes the potential for biosimilar products to be at a disadvantage to reference products for the Medicare-eligible population in the coverage gap.