Life Science Compliance Update

November 17, 2017

FDA Approves Sixth United States Biosimilar

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Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira and sixth biosimilar in the United States. “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals.”

More Details

Cyltezo is a tumor necrosis factor (TNF) blocker approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis. In addition, adalimumab-adbm is approved for children aged 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.

A biosimilar is a drug that has been demonstrated to be "highly similar" to the already-approved reference product. "The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products," FDA explains.

Future Biosimilar Predictions

As reported by Regulatory Focus, Bernstein biotech analyst Ronny Gal told investors in a note that adoption of biosimilars in the EU “continues to surprise to the upside” as member states have increased their adoption.

“Prices are lower (say ~50% discount of pre-biosimilar entry) and the commercial model is supported by very light marketing requirements. Further, the number of late-stage competitors in key markets (Enbrel, Epogen, and Remicade) is only 3-4, suggesting continuation of profitability. The big upcoming test is the adoption of the oncology products (Rituxan launched and Herceptin expected). Neulasta will presumably launch in 2018 and will do very well in the EU markets,” Gal wrote, according to Regulatory Focus.

For the US marketplace, Gal points to “two key speed bumps”: Approvals of Epogen and Neulasta have been delayed for a year and the Remicade biosimilars approved in April 2016 and last April have “failed to gain traction, exposing some weaknesses in the US market when it comes to encouraging biosimilars and casting doubt on the market,” though he expects this to change in the next 12 months. In terms of other predictions, Gal said Epogen and Neulasta biosimilars will launch in the US though he expects “relatively weak adoption” before the end of 2018.

May 09, 2017

Biotechnology Investors Beware?

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One thing the pharmaceutical stock industry has seen over many decades is price sensitivity to small statements and comments made by those in the public eye. Recently, Jim Greenwood, President and CEO of the Biotechnology Innovation Organization (BIO), authored an article on Medium about why those working and investing in the biotechnology industry should not be concerned, industry is on a successful path forward.

Greenwood noted that while investors do not do well with uncertainty, there is now more stability and less of a likelihood that biotech markets will radically move with a just one press conference or interview.

Greenwood also refreshed our memories about the BIO “Value Campaign,” which has two goals: (1) to cultivate political allies and (2) to change the conversation on price to a conversation on value. BIO wants “people to understand that biotech companies do more than manufacture pills and biologics. They offer the most precious thing of all: more time to spend with our loved ones.”

The fact that Donald Trump wants to bring down drug prices has been made evident. However, Greenwood notes that the biopharmaceutical industry shares that goal, but believes that rather than add restrictions and regulation, a greater emphasis needs to be placed on the free market. He has seen the success of diverse CEOs who spend their time gathering information, from a variety of sources, and the correct calls they wind up making.

Greenwood notes,

For instance, some counseled the President to put at the helm of the Food & Drug Administration a leader who might take a radically different approach to drug approvals. Others advised him that it’s critical for patients and innovators for the FDA to remain the global, gold standard. The President has since nominated Scott Gottlieb, who believes we can have meaningful regulatory reform without compromising on safety or efficacy. President Trump has chosen known entities and strong free-market reformers to lead FDA and the Department of Health and Human Services. This is actionable intelligence for investors, far more so than any single Tweet or quote. There’s a saying in Washington that “personnel is policy.” Savvy investors who’ve studied the positions and credentials of President Trump’s key personnel choices are rightly confident about placing bold bets on biotechnology stocks.

Just the Facts, Ma’am

Greenwood goes on to discuss the PR gambit insurance companies and the media have partaken in, wherein they unleashed a torrent of media attacks against drug makers, enlisting universities and think tanks to help them. Patients, unfortunately, have fallen for this nonsense. They pin the fact that the insurance company is refusing to cover their medicine, thereby increasing co-pays, on the drug company instead of the insurer.

However, the national share of health care spending on medicines remains the same today as it was fifty years ago – roughly ten to fourteen percent. Greenwood notes that insurers spend a lot of time pointing the finger at industry for rising premiums, but that is not true. About 75% of insurance premium growth is driven by increasing payments to hospitals and doctors – only 17.7% of premium increases in the ACA market come from prescription drug costs.

This degree of cost-shifting is not happening in other sectors of health care. Patients have to pay just four percent of their hospital bill, on average, but insurers make them pay a cost-sharing percentage five times greater for their medicines.

Greenwood then attempts to set the record straight, noting:

First, drug companies don’t set patients’ out-of-pocket costs. Insurers do. Second, rising drug prices are not the real driver of health care costs. Medicine keeps people out of hospitals and doctor’s offices, which are the primary cost drivers.

Greenwood concludes by mentioning the roll out of www.drugcostfacts.org, a portal filled with facts (each with multiple sources), with information changing regularly, depending on what is being debated in Congress.

February 10, 2017

FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and Biosimilars

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Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to biologics and biosimilars. The guidance, titled “Nonproprietary Naming of Biological Products,” finalizes an August 2015 draft of the same title. In the final guidance, the FDA says a biologic product’s nonproprietary name (“proper” name) will consist of two components: a “core name” and a distinguishing suffix (with no specific meaning) composed of four letters. The FDA, however, did not finalize an approach to the suffix format for interchangeable products.

Scope

The FDA intends to apply the naming convention to both newly licensed and previously licensed biological products. The FDA is also continuing to consider the process for implementation of the naming convention for previously licensed products but, for right now, intends to assign distinguishing suffixes to a limited group of these products and will accept submissions of prior approval labeling supplements that include proposed suffixes.

Core Name

FDA says the core name will be the name designated by the USAN Council for the originator biologic product, and that any related biological product, biosimilar product, or interchangeable product will have the same core name. The FDA notes in the guidance that “use of a shared core name will indicate a relationship among products.”

Distinguishing Suffix

For the second component of a product’s proper name, the FDA says “a distinguishing suffix that is devoid of meaning and composed of four lowercase letters will be attached with a hyphen to the core name of each originator biological product, related biological product, or biosimilar product.” The agency notes that its choice of using a suffix rather than a prefix will help products with the same core name being grouped “together in electronic databases to help health care providers locate and identify these products.”

Inadvertent Substitution

The finalized naming approach “should help prevent inadvertent substitution” which can lead to “unintended alternating or switching of biological products that are not determined by FDA to be interchangeable with each other,” the agency says. The FDA notes the distinguishing suffix should clear up potential confusion when related biological products are licensed for different indications, different routes of administration, or fewer than all indications for which the reference product is licensed.

The FDA also says the unique suffix should also prevent confusion among health care providers who, “based on their experience with small-molecule drugs and generic versions of those drugs, may incorrectly assume that FDA has determined biological products with the same proper name to be interchangeable.”

Interchangeability

In the guidance, the FDA says that it is continuing to consider the appropriate suffix format for interchangeable products. The FDA says it intends to apply a naming convention to interchangeable products that will feature a core name and a suffix included in the proper name; however, FDA is continuing to consider the appropriate format of the suffix for these products.

In addition, FDA requests that biologic and biosimilar applicants and application holders propose a suffix composed of four lowercase letters for use as the suffix included in the proper name.

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