The Center for Biosimilars Staff

During the second day of the 36th Annual J.P. Morgan Healthcare 

, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar competition.

Amgen’s Biosimilars Portfolio Eyes a Share of $65 Billion in Global Sales

Amgen’s chairman and CEO, Bob Bradway, reported that biosimilars will provide an important driver of Amgen’s long-term growth; in addition to launching its adalimumab biosimilar (Amjevita) in the European Union during 2018, and receiving an approval for its bevacizumab biosimilar (Mvasi) last year, Amgen has filed its ABP 980 (trastuzumab) biosimilar for regulatory approval, and is in phase 3 development of ABP 710 (infliximab) and ABP 798 (rituximab) biosimilars.

Amgen is in phase 1 development of an eculizumab biosimilar, and process development of a cetuximab biosimilar, as well as 3 additional molecules. In total, the originator drugs that Amgen’s biosimilars are targeting totaled approximately $65 billion in worldwide sales in 2017, said Bradway.

At the same time, Amgen expects that it will be able to retain a substantial hold on market share for 2 of its originator biologics that face upcoming biosimilar competition. Bradway reported that Amgen’s reference pegfilgrastim (Neulasta) has seen strong success with its Onpro kit, sales of which accounted for 60% of Neulasta sales in the fourth quarter of 2017.

Bradway also noted that Amgen continues to “make strategic investments” in its originator etanercept (Enbrel), which will retain its US patent exclusivity through 2029, despite the approval of a biosimilar, Erelzi.

Mylan: Pegfilgrastim Biosimilar a Potential “Mid-Year 2018 Opportunity”

In a “fireside chat” presentation, Heather Bresch, Mylan’s CEO, and Rajiv Malik, company president, also highlighted progress with biosimilars. Bresch noted Mylan’s 2017 win with the approval of “our Herceptin,” Mylan’s Ogivri.

Bresch, saying that her company has one of the most robust biosimilar pipelines in the industry, did note that the market for biosimilars—as well as for generics like the multiple sclerosis drug glatiramer acetate (Copaxone), which she said was in a similar “bucket” with respect to marketplace challenges&mdash;will present a steep industry learning curve as US states address issues of substitution of drugs. Ultimately, she said, “affordability and access is going to drive necessity” for these products.

Malik added that Mylan’s pegfilgrastim biosimilar, which 

 a complete response letter from the FDA in October 2017, may be a “mid-year 2018 opportunity” for FDA approval. Malik said that “we believe that our mostly scientific issues have bene addressed,” and that the quality issues related to its manufacturing facility have been resolved.

Roche Looks to Combinations for Herceptin, Rituxan

Roche, maker of numerous biologics targeted by biosimilar developers, noted its December 2017 approval of pertuzumab (Perjeta) plus trastuzumab (Herceptin) in HER2-positive early breast cancer, a combination that could help the company to forestall competition from Mylan’s biosimilar trastuzumab when launched.

Additionally, with oncoming biosimilar competition for its reference rituximab, Rituxan, Roche highlighted positive results of studies of its polatuzumab vedotin plus bendamustine versus rituximab plus bendamustine in phase 2 study in treating B-cell malignancies. It also reports that its development program of venetoclax includes venetoclax plus rituximab versus bendamustine plus rituximab in patients with chronic lymphoid leukemia, acute myeloid leukemia, non-Hodgkin lymphoma, and multiple myeloma.

Roche also noted the successful recent launch of its multiple sclerosis drug ocrelizumab (Ocrevus), saying that the therapy has achieved a “broad base of prescribers and a high level of US insurance coverage,” as well as the potential of its atezolizumab (Tecentriq) to achieve new therapeutic combinations by 2020. Tecentriq is currently under investigation for combination with such drugs as bevacizumab (Avastin) for the treatment of non-small cell lung cancer.

Sanofi Eyes Sotagliflozin in the Face of Follow-on Insulin Competition in the Diabetes Market

Olivier Brandicourt, CEO of Sanofi, highlighted the company’s work on sotagliflozin for the treatment of type 1 and type 2 diabetes. Sanofi has 

 substantial competition for its insulin products in the United States since Boehringer Ingelheim launched its follow-on insulin glargine (Basaglar), and now finds 2 of its patents for its reference product under review by the US Patent Trial and Appeal Board after a challenge by Mylan.

According to Brandicourt, Sanofi showed steady financial performance despite its decline in diabetes sales (expected to total 6% to 8% for the 2015 to 2018 period), but nevertheless, the company sees sotagliflozin as promising on its positive data showing weight reduction, improved time in range in type 1 diabetes, strong glycated hemoglobin reduction, and reduction in the number postprandial glucose excursions, with no increase in hypoglycemia.

Articles

During the second day of the 36th Annual J.P. Morgan Healthcare Conference, Amgen and Mylan highlighted their progress with biosimilar therapies, while Roche and Sanofi focused on progress with innovator products and combinations that may help insulate them from biosimilar and follow-on competition.

Amgen and Mylan Highlight Biosimilar Wins, Roche and Sanofi Look to Innovator Products in Second Day of J.P. Morgan Healthcare Conference

On the first day of the 36th Annual J.P. Morgan Healthcare 

, biosimilar developers Coherus, Pfizer, and Teva all laid out their strategies for the year ahead.

Cohreus Has “Very Good Reason to be Optimistic” About Pegfilgrastim Biosimilar

Coherus’ CEO, Dennis Lanfear, highlighted his company’s progress on CHS-1701, a proposed pegfilgrastim biosimilar that 

 a Complete Response Letter (CRL) from the FDA in June 2017.

Lanfear reported that, in response to the FDA’s concerns—acknowledging that “[the FDA] are being appropriately cautious” about immunogenicity&mdash;Coherus redeveloped and validated its immunogenicity assay for the drug, and has discussed its validation with the FDA. It also reports that it has addressed manufacturing issues related to the proposed drug.

Currently, the company is preparing to resubmit its pegfilgrastim Biologics License Application to the FDA and to submit a marketing authorization application to the European Medicines Agency (EMA). Lanfear said that Coherus expects a 6-month FDA review cycle, putting the drug’s potential US approval on track for the third quarter of 2018, as well as potential European approval by mid 2018.

Lanfear also reported that CHS-3351, a proposed ranibizumab (Lucentis) biosimilar, would initiate clinical development in 2018, and that CHS-2020, a proposed aflibercept (Eylea) biosimilar has initiated preclinical development.

Coherus’ anti—tumor necrosis factor (anti-TNF) biosimilars—CHS-0214, a proposed etanercept biosimilar, and CHS-1420, a proposed adalimumab biosimilar&mdash;continue to face legal delays; Coherus has pending inter partes review petitions concerning patents covering etanercept (institution decisions are expected in March 2018), and the company is also awaiting patent expiry for reference adalimumab.

Despite Coherus’ potential in ophthalmology and anti-TNF candidates, Lanfear said the company is currently “focused very tightly” on pegfilgrastim, seeking to “block and tackle our way right through the [CRL].”

Pfizer’s “Rich Data Delivery Year” for Innovator Products

Mikael Dolsten, MD, PhD, president of worldwide research and development for Pfizer, said that, far from seeking to be “a follow-on company,” Pfizer, developer of 2 FDA-approved infliximab biosimilars, Inflectra and Ixifi, is focusing heavily on bringing innovator products to the market.

Saying that the company “focused on rigorous science [and] crisp decision-making” to reallocate resources away from its neuroscience research division, Dolsten reported that Pfizer has the potential for up to 15 “blockbuster approvals” by 2020, including 5 products in oncology (inclusive of targeted cancer agents), a Janus kinase (JAK) 1 inhibitor for the treatment of atopic dermatitis, and a JAK ‘X’ for the treatment of alopecia and vitiligo.

Subject to attrition, said Dolsten, sales of Pfizer’s potentially approved drugs are anticipated to exceed $1 billion in the coming 5 years.

2018 will also be “a rich data delivery year,” said Dolsten, with:

US and EU action dates for its JAK inhibitor Xeljanz in ulcerative colitis

Phase 3 data forthcoming for the novel biologic tanezumab for the treatment of pain

Phase 1 data for a JAK3 inhibitor for the treatment of rheumatoid arthritis

Phase 1 data for an anti—IL-33 drug for the treatment of atopic dermatitis

Phase 1 and 2 data on TFPImAb for the treatment of hemophilia

Teva Is “Not Chopping Up the Company”

Kare Shultz, president and CEO Teva, which is jointly developing biosimilars referencing rituximab and trastuzumab with Korean drug maker Celltrion, tried to allay investor concerns about the company’s major restructuring, which has included 

“We…are divesting some of our non-essential assets,” Shultz said. “We are not chopping up the company. We are going to optimize and make the way we provide our products more efficient.”

That efficiency will be provided through consolidation of offices, layoffs in research and development departments, the shuttering of factories, and reductions of active pharmaceutical ingredient sites from 80 to approximately 8 to 10.

With savings generated by these cutbacks, Teva plans to pay down its $3.2 billion in debt.

Shultz put a positive spin on his report, saying that the company still has the ability to do early clinical trials, which are “some of the best in the world,” and that “We’ll launch more generics and biosimilars than anyone else.”

On the first day of the 36th Annual J.P. Morgan Healthcare Conference, biosimilar developers Coherus, Pfizer, and Teva all laid out their strategies for the year ahead.
 

Coherus, Pfizer, and Teva Look to Year Ahead at J.P. Morgan Healthcare Conference

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb (Humira) in the Indian marketplace this week, 

The drug, which will be marketed as Adaly, has launched at an undisclosed price discount to the reference product, and will be commercialized under an agreement with Cadila Healthcare. 

"The launch of Adaly reaffirms our commitment toward meeting unmet needs of patients and providing the latest treatment options,” Sujesh Vasudevan of Glenmark told the 

News of Adaly’s launch follows close on the heels of another biosimilar adlaimumab’s Indian market entry: on January 3, drug maker Hetero launched its own biosimilar drug under the brand name 

. Both new biosimilars enter a marketplace in which drug maker Zydus has already launched a biosimilar adalimumab, under the brand name 

, which came on the market in 2014 as the world’s first commercially available biosimilar adalimumab product.  

While the Indian marketplace will now have additional, cost-saving options available, patients in other areas of the world face a longer wait for biosimilar adalimumab. In September 2017, drug maker Amgen announced that it had reached a 

 with Humira’s sponsor, AbbVie, after a lengthy patent dispute. The settlement, the terms of which were not disclosed, cleared Amgen to launch its biosimilar—Amjevita&mdash;in the United States in 2023 (despite the drug having been approved by the FDA in September 2016). Amgen fared slightly better in the European Union, where it will be allowed to introduce the drug in October of this year.

As the European and US markets await biosimilar availability, AbbVie has raised prices on the innovator Humira by 

 for 2018, an increase that is estimated to cost the US healthcare system an 

 $1.2 billion this year alone. In 2016, Humira garnered $16.08 billion in global sales—up 14.7% from the previous year&mdash;making the reference adalimumab the top-earning drug worldwide.

Mumbai-based Glenmark Pharmaceuticals launched a biosimilar adalimumb, Adaly, in the Indian marketplace this week, following Hetero's launch of Mabura.

India Gains 2 Adalimumab Biosimilars in 1 Week as United States, Europe Await Market Entry

Hi, I’m Kelly Davio for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars. 

Here are the most-read biosimilars articles for the year of 2017.

Number 5: In January, The Center for Biosimilars

provided a look at the marketplace for prospective biosimilars referencing Humira, Enbrel, and Remicade. 

approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri,

Number 3: In January, Pfizer announced that 

CMS would reimburse for its biosimilar infliximab.

Number 2: In September, the FDA released a 

 noting observations that it made when inspecting Celltrion’s manufacturing facility earlier in 2017.

issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar,

To read all of these articles and more, visit centerforbiosimilars.com.

The Center for Biosimilars recaps the most-read articles of 2017.

The Top 5 Biosimilars Articles for 2017

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017. 

The 4 Key Legal Developments in Biosimilars in 2017

2017 brought a number of notable guests to The Center for Biosimilars

. Below are the most-watched interviews of the year:

Number 5: Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.  

Number 4: Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the importance of pharmacist education on biosimilar treatments.

Number 3: Joseph Fuhr, PhD, explains why biosimilars could bring on brand-to-brand competition.

Number 2: Angus Worthing, MD, FACR, FACP, discusses the benefits of biosimilar medicines.

Number 1: Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses incentives for biosimilar applicants to engage in the BPCIA "patent dance" after the Supreme Court's ruling in 

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year. 

The Top Biosimilars Interviews of 2017

The United States now has 9 FDA-approved biosimilars. Our latest infographic breaks down what you need to know about these products.  

Infographic: The 9 FDA-Approved Biosimilars

Here are the top 5 biosimilars articles for the week of December 18.

Number 5: A newly published study shows that adalimumab is effective in treating 

Number 4: Mylan announced that the US Patent Trial and Appeal Board has instituted 

inter partes review proceedings on all claims against 2 patents

Number 3: Tax disclosures show that industry group 

PhRMA spent millions on lobbyists, politicians, and patient groups

Number 2: Attorney Kevin Nelson, partner at Schiff Hardin, 

explained the impact that the federal circuit’s ruling in 

Number 1: The FDA has accepted for review Samsung Bioepis’ 

Finally, last week, our e-newsletter asked whether you think that the FDA has become more lenient in approving drugs under current leadership. To view results of the poll, 

The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 2017.

The Top 5 Biosimilars Articles for the Week of December 18

Here are the top 5 biosimilars articles for the week of December 11.

Number 5: Industry trade and lobbying group PhRMA 

sued California state officials in federal court

 over the state’s new drug pricing law, which the group calls “unprecedented and unconstitutional.”

Number 4: In a new comment letter, the American College of Rheumatology praised the FDA for considering ways to reduce regulatory burden, but 

called on the FDA to focus on 6 minimum components of review and oversight for biosimilars.

 that state law cannot compel drug makers to comply with the so-called patent dance.

FDA has granted final approval to the first short-acting follow-on insulin product,

approved Pfizer’s second infliximab biosimilar, Ixifi.

Finally, last week, our e-newsletter asked whether you think the United States should follow the European Commission’s lead in requiring industry to produce consensus documents on biosimilars. To view results of the poll, visit us on 

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

The Top 5 Biosimilars Articles for the Week of December 11

Are biosimilars going to play a big role in value-based design?

The question about whether biosimilars play a role, branded drugs play a role, generics play a role, I think all of these questions about specific interventions take us back to what makes VBID different from other types of payment insurance schemes which is this era of clinical nuance.

It has always been our view that the value of a service depends not on the service itself, but who gets it, when in the course of the disease, by whom, and where. So, whether that be a branded drug, a generic drug, a specialty drug, or a biosimilar, there is a time in the course of the sequence of care where drugs are considered very high value, and that exact same drug might be considered low-value.

So as opposed to talking about preferred branded drugs or specialty drugs or biosimilars or generics, as many people know, there are some generics that I would pay people to take. There are also some generic drugs I would not give my dog. The same holds true for biosimilars. If there is evidence to suggest that a biosimilar at this point in time is a first-line drug, then the patient should have access to that and the provider should not have problems in terms of having to send faxes or make phone calls or whatever else to use it.

But that requires not just transparency, not just consumerism, not just skin in the game. This requires clinical expertise that fortunately or unfortunately most patients just don’t have. So instead of relying on patients to shop around, and make these types of decisions, I think the onus should be on providers. They for the most part want to do what’s best for their patients. We need to have their compensation systems aligned with good choices, but more importantly if a provider decides that something is best for his patient, whether that be a biosimilar, whether it be a specially drug, whether it be a branded drug or generic, when that clinical situation says that this is the right service for that person at this right time, there should be unfettered access to that.

So, I think in the avdent of any innovation, like biosimilars or maybe more importantly, these new CAR-T therapies moving forward, we need to access not only the clinical benefits that have come to them, not only the cost for which it has incurred, but understanding that drug and that cost, the value of which depends on the clinical scenario that it might be. It might be so important that you want barriers to fall and in some patients to do it, the exact same drug may be a complete waste and in another patient another scenario. And I think that’s where VBID fits in.

Videos

Mark Fendrick, MD, discusses the role that biosimilars will play in value-based insurance design (VBID).