In lieu of the slow development of the U.S. biosimilar market, the FDA has stepped up to determine how it can improve biosimilar education, regulation, and market access. As many of the industry comments to the Biosimilar Action Plan revealed, this will require the FDA to continue broadening its purview and refining the regulatory pathway by implementing several specific actions.
In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.
Though it’s much too early to say for sure, we will need to watch how this formulary impacts the brand vs. biosimilar landscape, and, in turn, the performance of biosimilars in the pharmacy reimbursement space.
On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.
The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.
While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.
I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.
With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry.
In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.
There are many challenges to walk through to truly understand the opportunity, the risks, and the best path forward for biosimilars, but the best thing would be to start by recognizing the external and internal risks that likely every player in the space is facing.
One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.
In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.
In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilars. This article discusses two significant elements of the BAP.
In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.
Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.
Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.
A decade after the primary negotiations that resulted in the BPCIA, it is safe to say the promise of biosimilars is yet to be realized. As it turns out, perhaps naivety, in a clinical sense, is the solution.
Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?
In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time.
Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.
In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.
I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.
Though the extent to which biosimilars will be used in Brazil is still unclear, I’m hopeful that several discussions on safety, efficacy, and interchangeability will provide a successful path forward for the country.
This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.
I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.
Often there is a great deal of confusion regarding why manufacturers wait so long to market their biosimilars despite having a more abbreviated pathway than innovator biologics. Other times, manufacturers and investors will be caught off-guard when a court blocks marketing of their biosimilars despite them having obtained FDA approval. Mitigating preventable uncertainty warrants understanding some of the underlying mechanisms related to the “patent dance.” This is the first of two articles that will address the patent infringement issues often used against biosimilars by sponsor biologic owners to delay or derail marketing of the biosimilar.
This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.
Green Shield Canada, a private payer, has created a biosimilar policy and is currently rolling out a pilot biosimilar transition program among its clients. Though it’s still in the early stages, this is an intriguing program to keep our eyes on as the market advances in Canada.
In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.
Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent of all U.S. prescribed drug spending.
The first biosimilar was approved for the European market in 2006. While the regulatory pathway for biosimilars in the U.S. was created as part of the Affordable Care Act in March 2010, the first biosimilar was only recently approved for the U.S. market in March 2015.
Biosimilars are essentially generic versions of large molecule biologics. However, the fact they are not exact copies of the reference product makes establishing regulations for their approval and release to market a more complicated process. The WHO, along with many other parties in the pharmaceutical industry, has argued that regulations governing the development and approval of small molecule generics are not appropriate for more complex biological medicines. As such, the WHO set out to establish regulations articulating the efficacy, safety, and quality standards biosimilars must meet and maintain to make it to market. These regulations specify that a biosimilar must prove its biosimilarity to a reference product through head-to-head comparisons. The biosimilar company must also submit non-clinical and clinical studies data and a pharmacovigilance plan to the appropriate regulatory body. Those navigating the landscape of current biosimilars regulations face the challenge of demonstrating a biosimilar’s safety, purity, efficacy, and potency.
The current U.S. Food and Drug Association (FDA) and European Medicines Agency (EMA) regulations for biosimilars require these biologic copies to undergo extensive analytical chemistry, manufacturing, and control (CMC) and clinical processes to prove similarity to the reference product. However, in comparison to the originator biologic, a biosimilar could see an accelerated approval process, as it might need less data to meet the established regulations. The EMA was the first regulatory authority to establish marketing regulations for biosimilars in 2005. Other countries including Australia, Canada, Japan, Korea, and South Africa have since turned to the EMA’s regulations, as well as the WHO’s regulations, as a model for crafting their own regulations. In 2012, the FDA released three draft guidances to assist biosimilar developers in demonstrating their product’s biosimilarity. To comply with existing U.S. regulations, manufacturers are expected to include structural analysis, functional assays, and data from animal and human clinical trials in their applications. As biosimilar production spreads globally, regulations have continued to shift and evolve. Currently, each governing body has differing definitions/terminology for biosimilars, and as such, has established varying regulations dictating what studies and data are needed to be approved for the market.