Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 4, 2022.

Number 5: During its annual conference in Sitges, Spain, Medicines for Europe 

 for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

Number 4: So far in 2022, the United States has 

 in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).

 for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Number 1: Shanghai Henlius Biotech announced the commencement of a 

 for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of July 4

Julie M. Reed, the executive director of the Biosimilars Forum, explains what needs to be done to ensure progress on biosimilar legislation and lower drug prices.

Lowering drug prices seems to be the one issue Republicans and Democrats can agree on but efforts to do so, including ones that could increase biosimilar access, are often stalled. What needs to happen to get these policies implemented?

They need to be prioritized and we need action. When we have opposition against these bills, we hear from policymakers that they’re hearing the market’s working fine. That is, there's depth—several different lenses to look at how the market is doing. The market is working where there's robust competition and access because you're seeing that competition and access lower the prices and you're getting greater cost savings. That's the goal here.

Where the market is not working is if you don't have access or don't have robust coverage of multiple biosimilars; you are not seeing the robust pricing competition and cost savings. So, I think it's very important that when it has bipartisan support. We’re leaving cost savings on the table—and billions of dollars in cost savings. And I think we're not the only ones shouting this from the hilltops. Academics are shouting it, researchers are shouting it, legislators are shouting it, patient groups and providers are shouting, like, “Help us get access to biosimilars because we need to treat our patients and we need to have cost savings!” And so, we need action. We need the action, and I hope we see it.

Julie Reed Explains How to Push Forward Bipartisan Biosimilar Legislation

Here are the top 5 biosimilar articles for the week of June 27, 2022.

Number 5: Abstracts from the 2022 European Hematology Association (EHA) Congress presented 

 for 2 biosimilar candidates referencing Soliris (eculizumab): Amgen’s ABP 959 and Samsung Bioepis’ SB12.

 before a rheumatologist could help improve biosimilar adoption rates and mitigate the nocebo effect in patients with chronic diseases, according to a recent study.

 of 2 biosimilar assets and start of development for 2 others provided hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

Number 2: The European Committee for Medicinal Products for Human Use (CHMP) 

 for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

Number 1: Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicled the current efforts to 

 from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

The Top 5 Biosimilar Articles for the Week of June 27

Although a lot of discussion regarding biosimilars has focussed on patient access, we need to divert more attention to the reliability of companies making biosimilar products, said Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis.

What types of conversations regarding biosimilars do we need to be have more of?

Patient access, we've heard a lot about. The other thing that we'd heard less about probably is the issues around surety of supply, which you get through having multiple manufacturers. But it's also an issue where you need to know that the companies sponsoring the products are reliable. And that's where I'd put one pitch in for Samsung Bioepis as if you've done the science right from the beginning, then everything else is an opportunity. And if you've got state of the art manufacturing. So, an issue that came out of COVID-19, of course, is reliability of the drug supply. And so you need to have capacity and you need it to be reliable.

Gillian Woollett Speaks on Where Biosimilar Conversations Need to Go Moving Forward

Here are the top 5 biosimilar articles for the week of June 20, 2022.

 for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

Number 4: Abstracts from the American Society of Clinical Oncology (ASCO) annual meeting took a look at the impact biosimilar 

substitution and increased biosimilar adoption

 had on spending within practices participating in value-based payment models and the Oncology Care Model.

Number 3: STADA Arzneimittel and Alvotech 

 of their high-concentration, citrate-free adalimumab biosimilar (Hukyndra) in France, Germany, Finland, and Sweden, with more European countries to come.

Number 2: Not long after the company announced its 

 to promote access and increase adoption of biosimilars, Sandoz’ application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

Number 1: Iceland-based Alvotech announced that the pureplay biosimilars company is 

The Top 5 Biosimilar Articles for the Week of June 20

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discussed the different options that payers have to manage the growing number of biosimilars referencing Humira (adalimumab) that are expected to enter the market in 2023 and beyond.

How do you think payers are going to manage having so many adalimumab biosimilars to choose from?

That's what we do as a company: we help people make formulary and drug management decisions. So, I see there's 3 options. As a payer, you can stay with AbbVie’s [product] all the way, which avoids member disruption and makes things more smooth but you don't get biosimilar adoption. And from an optics perspective, I think adoption of biosimilars is becoming more required these days.

So, one option is AbbVie, all in. You may not get quite as much savings as going with biosimilars, but you also now don’t have some of the hurdles and hassles you get with going with biosimilars.

Number 2 is going middle of the road. Keep Humira [reference adalimumab] on formulary, but also add some biosimilars at parity. So, have both options available. It allows you to maintain some Humira rebate and also allows you to take advantage of some biosimilars savings. So that's option 2, kind of meeting halfway.

And then the last one is biosimilars, all in. Take [Humira] off formulary and go all in with biosimilars. Try to convert as much of the market share as you can.

So, those are the strategies, and as far as all those different options you probably add the [originator], and/or 1 or 2 of the biosimilars, and then see how the cards fall.

How Will Payers Manage Multiple Adalimumab Biosimilars? Jeffrey Casberg Explains

The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.

What sort of policy initiatives should legislators and the FDA be putting a greater focus on?

This is really the critical year, and we need the administration to follow up on the President Biden's executive order to do more with biosimilars; it's almost a 1-year anniversary. So, we need CMS to get some biosimilar programs out there. We've been talking for a long time and they're leaving cost savings on the table. [It's] really important, especially now.

So, that's one piece of it; the administration needs to act and follow up. In Congress, biosimilars have been a bipartisan solution for a number of yours. But unfortunately, politics have stopped some of our ideas and that are supported, as I mentioned, by both sides in the House and in the Senate. [Reimbursing at] ASP [average sales price] plus 8%, shared savings, and $0 copay. Those things need to happen, especially with the [adalimumab biosimilar] launches next year and [the biosimilars] launching in ophthalmology. We've launched a interchangeable insulin biosimilar. All these products are coming to fruition, yet patients don't have access to them.

And so, we need the administration and Congress to do something. The other piece, about the FDA, we, as stakeholders and partners with the FDA, have to get the BsUFA [Biosimilar User Fee Amendment], the super 3 pac that's critical, and then we have to partner with the FDA to to evolve the program through the science regulatory science program. So, that's really key. And then continue, like I said, our partnerships with the other agencies, like the FTC, the FDA, and CMS, to do everything we can to make us more successful.

Julie Reed: Biosimilar Policies Legislators Should Be Prioritizing

During an interview from the Festival of Biologics, Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.

How has the conversation surrounding biosimilars evolved since the US introduction of biosimilars in 2015?

I think one thing that we saw had been somewhat put to rest in recent discussions is any questions around quality of the biosimilars or any unusual or unexpected adverse events, such that those that are experienced in their use are increasingly comfortable as further biosimilars come along.

But in that sense, it's slightly dependent on therapeutic area because say you've had experience with oncology biosimilars, you're comfortable with future oncology biosimilars. So, I think there was a discussion that the business model is more, perhaps, governed by therapeutic area than it is either a more generic model or a more brand model.

So, I think that was one important point, but it does come down to: the science is the bedrock of everything. That if you're consistent as a regulatory authority, it's important for both the confidence in the biosimilars but also the confidence in the regulators, that they're consistent and science-based. 

There's an opportunity for much, much greater regulatory efficiency. And that came up, again, as a global issue, perhaps in part due to some of the experiences from COVID-19 but also a general agreement that the science is worldwide. And if we can show some regulatory efficiency, we can get more competitive products more quickly and more affordably. But also we may keep more competitors in this space. So, that was really important, too.

And then there was amongst some, not amongst everybody, the view that, of course, we need biosimilars to allow room in the health care dollar for the next tranche of innovator products, too. And that affordability across the board is as important as anything else to do with biosimilars insofar as everybody wants the originator biologics coming through. And of course, they're the future reference products for biosimilars. So, there was a little bit more optimism around the sort of virtuous cycle of ideas rather than being solely about specific products and some companies feeling a threat to their portfolios.

Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.

Gillian Woollett Catalogues How Conversations Surrounding Biosimilars Evolved

Here are the top 5 biosimilar articles for the week of June 6, 2022.

Number 5: Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced 

 compared with the original Remsima, an infliximab biosimilar delivered intravenously.

Number 4: Posters presented at the American Society of Clinical Oncology (ASCO)'s annual meeting showed the 

 health systems took to encourage greater adoption of oncology biosimilars.

Number 3: With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering 

 for the US market, Amneal Pharmaceuticals and Kashiv Biosciences’ Fylnetra (pegfilgrastim-pbbk), referencing Neulasta.

Number 1: Samsung Bioepis and Biogen announced that 

 on the US market as the first ranibizumab biosimilar referencing Lucentis, listed at a 40% discount compared with the originator.

The Top 5 Biosimilar Articles for the Week of June 6

Savings generated from biosimilar utilization could be used to promote innovation for new therapies or funding for more health care services, said Julie M. Reed, the executive director of the Biosimilars Forum.

Besides savings, what other benefits can increased biosimilar utilization provide?

If you think about how costly these are. We're aware [that these could cost] tens of thousands of dollars and some monthly. So, if a patient is paying out of pocket for their co-pay or anything like that, that's really big. Think about it just on a daily basis, especially with today's inflation and everything else, how concerning it is for patients who may not have insurance, they may not have any access to these products.

We're working with provider groups to help improve health equities, and if you think about health equity and equity just to care and services and medicines, biosimilars are a key piece, just like generic drugs. If we didn't have lower-cost biosimilars on the market, patients may not have any access to these medicines, and that's a very, very difficult choice. So, that access, that whole promise that lowering cost leads to greater access and more patients can have these products.

The other piece is on the innovation side. And this is what we see in other countries, in Canada and in the United Kingdom, where the government and the stakeholders have the savings. So, they have savings, and they can take that money and invest it in new innovative therapies that they perhaps could not have afforded or given access to patients to before. Or in some countries, they’re investing all the savings into services they didn’t have before. So, they’re investing into education or more nurses or things like that. That’s the thing, [saying] like, “Wait, guys, you’ve got an opportunity to increase your budget for something else because you're saving on this side.” So, it’s key, it’s sort of a win-win for biosimilars, for patients, for health care providers. It’s also a win for innovators who are bringing out new innovative therapies that may have limited access because of cost. That I think is key and free market competition is is really the best policy, especially here in the US.

I mean, think about it, we’re developing gene therapies and all these things in rare disease therapies that have never been developed before and how are we going to pay for it? Well, you know what, let’s lower the cost on ones with biosimilars so we can pay for those new things. That’s an incredible opportunity we have. But it won’t just happen; we have to make it happen.