“Will 2021 be another break-through year for biosimilars?” asks Forbes in an article this month.

Written by healthcare analyst Joshua Cohen Pd.D., the article discusses the rising use of biosimilars which he calls “remarkable.”

“The latest data show that physician-administered biosimilar drugs are successfully displacing their reference biologics,” Cohen writes. “Newer biosimilars are being adopted faster than before, due in large part to declining prices.”

Biosimilars are sometimes confused with generic drugs. Though there are similarities, chiefly in that they have the same clinical effect as the more costly brand name formulations, the difference is that biosimilar drugs are highly similar, but not identical to the brand names. The other difference is that generics are copies of synthetic drugs, while biosimilars are based on drugs developed using living organisms such as bacteria, animal or plant cells.

Like generics, biosimilars are significantly less expensive than the brand name counterparts. These original drugs are referred to as “reference” or “originator” products.

As the chart prepared by the Drug Channels Institute shows, the market share of some of the newest biosimilars is growing rapidly.

Their use would increase even more rapidly, writes Cohen, if the Food and Drug Administration granted biosimilars interchangeability status. A biosimilar product that meets the requirements of the Biologics Price Competition and Innovation Act will be given interchangeable approval, meaning a pharmacy can substitute it for the original, brand name without the involvement of the prescribing doctor.

Currently, that’s one of two big obstacles to biosimilar sales. Doctors must specifically prescribe the biosimilar. Most do not out of habit, familiarity with the existing brand name and because so many health plans do not cover biosimilars.

As Adam J. Fein, PhD, CEO of the Drug Channels Institute, explains, “biosimilars are often not preferred over reference products at many of the largest U.S. commercial health plans. Physician preferences can slow adoption, too. A 2019 survey found that a majority (61%) of oncology physicians still prefer not to use biosimilars, use them only for supportive care, or prefer not to switch patients.”

Congress is expected to act next year on a bill with bipartisan support that incentivizes the use of biosimilars by changing the reimbursement formula for brand-name drugs and biologics, Cohen says. Since most biosimilars are physician-administered, improving the reimbursement rate is hoped to be enough of an incentive for doctors to make the switch.

One estimate from the Wall Street analyst firm Bernstein Research puts the annual savings from the use of biosimilars at $6.5 billion.

Calling 2020 an “inflection point,” Fein says, “The biosimilar market is finally beginning to fulfill its promise.”

Photo by Kendal on Unsplash

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Jun 6, 2023

Rare Diseases Trial Network Moves Closer to Reality

As many as 30 million Americans may be living with a “rare disease,” officially defined as a condition affecting fewer than 200,000 people.

The Genetic and Rare Diseases Information Center says there are some 7,000 known rare diseases. Most are genetic. Only about 10% of all rare diseases have an approved treatment.

To hasten the development of drugs and therapies, the Food and Drug Administration in 2019 began an initiative to “to facilitate a cooperative approach and common standardized platforms to better characterize rare diseases, incorporate the patient’s perspective in clinical outcome assessment measures, and build clinical trial readiness in the pre-competitive space.”

Dubbed the Rare Disease Cures Accelerator, the initial focus of the program is building “an integrated database and analytics hub designed to promote the secure sharing of existing patient-level data and encourage the standardization of new data collection.”

A second key part was to award grants “develop standard core sets of clinical outcome assessments (COAs) and endpoints for specific disease indications.”

In May, the FDA asked for input from industry, rare disease organizations, patients and others regarding the “implementation and sustainment of global clinical trials networks.”

“As drug development for rare diseases can be challenging due to the small number of patients and limited understanding of the variability and progression of the diseases, the FDA is committed to developing bold new approaches to harness the infrastructure of global clinical trial networks,” said Anand Shah, FDA deputy commissioner for medical and scientific affairs.

A recent report on Regulatory Focus, the website of the Regulatory Affairs Professionals Society, said the stakeholders who commented “called for regulatory clarity, smart use of existing resources, and a move toward harmonized trial standards and assessments.”

Several comments addressed the need to ensure the quality of the data collected as well as reducing and eliminating some of the challenges unique to rare disease trials.

On behalf of the Biotechnology Innovation Organization, Danielle Friend, senior director of science and regulatory affairs, said the networks need to support “the collection of high-quality data that are endorsed by the agency for regulatory decision-making.” She said a rare disease network must recognize and address “heterogeneity in rare diseases, lack of harmonization among global regulators in rare disease regulatory policy, and current inconsistencies in clinical trial network operation.” The FDA plan also should consider combining rare diseases into a single trial when possible.

The National Organization for Rare Diseases echoed those comments, and, according to Regulatory Focus, said “Increased collaboration and a focus on increasing the speed and success of clinical trials can have the effect of ‘breaking down the silos of activity currently taking place in rare disease research.’”

Now the FDA will analyze the comments, incorporating them into a development plan for its trials networks program. No timeline was given for this phase of the program.

Photo by CDC on Unsplash


Jun 6, 2023

Dramatic Changes Are Transforming the Legal Profession

The business of lawyering is undergoing a transformation that is as dramatic as it is still little recognized even by many in the profession.

As has been the case with so many other sectors of the economy, the COVID pandemic accelerated changes already occurring. Most obvious has been the rapid deployment of technology in ways that few in the field would have predicted even as recently as the beginning of this year.

Court appearances, hearings and chambers’ conferences that just months ago had to be conducted in person, are now routinely handled by video and phone. Legal filings are accepted online. Clients meet with their lawyer remotely. Law schools are teaching entirely online.

“The pandemic has liberated the legal industry from compulsory attendance at legal sanctuaries — offices, schools, and courthouses,” writes lawyer, legal entrepreneur and law professor Mark Cohen. “In a matter of weeks, the legal ecosystem became more agile, fluid, collaborative and efficient. This transition occurred with remarkable speed, pervasiveness, absence of resistance, and overall effectiveness.”

These innovations were born out of necessity. Courts couldn’t simply shut down completely, so judges and lawyers and their support staffs switched to the online model many other businesses did.

Now that the experiment has, as Cohen notes in his commentary on Forbes, “illuminated the opportunity for reimagining and improving upon old ways of delivering legal services, learning, and resolving disputes,” a complete return to tradition is unthinkable. “The genie is out of the bottle.”

The transformation, though, is not purely technological. Cohen points to Arizona and Utah, where the high court in each state approved sweeping programs to change law’s business structure and open the door to admit non-lawyers to the practice.

In August, the Utah Supreme Court unanimously authorized a pilot program to test changes enabling “individuals and entities to explore creative ways to safely allow lawyers and non-lawyers to practice law and to reduce constraints on how lawyers market and promote their services.”

Later that month Arizona’s high court removed a long-standing rule that prohibited non-lawyers from owning a law firm and other alternative business structures. The court’s order also permits the licensing of non-lawyers as paraprofessionals who will be able to provide some legal services to clients, including representing them in court.

The courts in both states established committees more than a year ago to study ways to improve access to legal services, so the two announcements didn’t come as complete surprises. Anticipating a loosening of the legal rules and recognizing the transformation of the profession, Deloitte, PwC, EY, and KPMG began enhancing their legal consulting practices.

Cohen says The Big Four “are each supplementing their legal talent pools by hiring well-known lawyers and business of law experts in an effort burnish their ‘legal’ credentials.”

As CEO of The Digital Legal Exchange, Cohen has a stake in promoting the transformation, especially the digital transformation, of the legal profession. Still, the evidence he cites and the articles he references, many written by him, makes a compelling case.

“Law,” he concludes, “Is not solely about lawyers anymore, and digital transformation, accelerated by COVID-19, will transform it just as it has its customers.”

Photo by Bill Oxford on Unsplash