Allison Inserro

Pregnancy in women with rheumatic and musculoskeletal disease (RMD) may lead to serious maternal or fetal adverse outcomes, but the majority of women with RMD can have successful pregnancies with adequate planning, treatment, and monitoring, the American College of Rheumatology (ACR) said Monday as it released the first clinical practice guideline regarding the management of reproductive health in this population.

2020 Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

 includes 12 ungraded good practice statements and 131 graded recommendations that are intended to guide care, except where indicated as being aimed at patients with specific conditions or antibodies present, such as systemic lupus erythematosus (SLE); antiphospholipid antibody, or APL (persistent moderate-to-high—titer anticardiolipin or anti–β2-glycoprotein I antibody or persistent positive lupus anticoagulant); or antiphospholipid syndrome (APS), either obstetric and/or thrombotic.

Taking into consideration patients’ values, preferences, and comorbidities, the guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, the ACR said.

The ACR said that “good practice statements are those in which indirect evidence is compelling enough that a formal vote was considered unnecessary.” They are presented as suggestions rather than formal recommendations.

While some of the recommendations are strong, many of the recommendations presented are conditional due to a lack of data. Pregnant women are not generally enrolled in clinical studies, and few maternal health studies focus on patients with these diseases, the ACR noted.

The recommendations are divided into 6 categories: medication use, contraception, assisted reproductive technology, fertility preservation with gonadotoxic therapy, menopausal hormone replacement therapy, and pregnancy assessment and management.

The guidelines make a strong recommendation against use of cyclophosphamide (CYC) and thalidomide in men prior to attempting conception, and a strong recommendation against the use of nonsteroidal anti-inflammatory drugs in the third trimester.

For biologic medications, the guidelines conditionally recommend continuing anti—tumor necrosis factor inhibitor therapy with infliximab, etanercept, adalimumab, or golimumab prior to and during pregnancy. In addition, the guidelines strongly recommend continuation of certolizumab therapy prior to and during pregnancy; certolizumab does not contain an Fc chain and thus has minimal placental transfer.

The guidelines conditionally recommend continuing treatment with anakinra, belimumab, abatacept, tocilizumab, secukinumab, and ustekinumab while a woman is trying to conceive, but discontinuing once she is found to be pregnant.

In addition, the guidelines conditionally recommend continuing treatment with rituximab while a woman is trying to conceive, and conditionally recommend continuing rituximab during pregnancy if severe life- or organ-threatening maternal disease warrants.

Patients with RMD typically underutilize effective contraception, the guidelines say, even though the risks of unplanned pregnancy include worsening or life-threatening disease activity as well as adverse pregnancy outcomes such as pregnancy loss, severe prematurity, and growth restriction. Congenital birth defects are another risk.

The guidelines specify a strong recommendation for women with rheumatic disease who do not have lupus or APS to use effective contraceptives. In addition, the guidelines provide a conditional recommendation to preferentially use highly effective intrauterine devices or a subdermal progestin implant.

In women who test positive for APL or APS, there is a strong recommendation against using combined estrogen-progestin contraceptives.

Fertility is typically normal in women with RMD, assuming they have not received treatment with CYC, the authors said.

The authors strongly recommend proceeding with assisted reproductive technology if needed in women with uncomplicated RMD who are receiving pregnancy-compatible medications, whose disease is stable, and who are negative for APL.

They make more specific recommendations for patients who test positive for APL and suggest an anti—blood clotting procedure. However, the guidelines provide a conditional recommendation against increasing prednisone dosage during fertility therapy procedures in patients with lupus.

For men, the guidelines state a good practice suggestion to cryopreserve sperm before CYC treatment in men, if they wish, and a conditional recommendation against testosterone co-therapy in men with rheumatic disease receiving CYC.

For women, the guidelines state a conditional recommendation for monthly gonadotropin-releasing hormone agonist co-therapy for premenopausal women with rheumatic disease who are receiving monthly CYC injections/infusions to prevent premature ovarian insufficiency.

The guidelines make a strong good practice suggestion to advise women who are considering pregnancy about the improved maternal and fetal outcomes associated with starting pregnancy during low disease activity.

The guidelines also make a conditional recommendation to treat patients lupus with low-dose aspirin daily (81-100 mg) starting in the first trimester. For women testing positive for APL who do not meet the criteria for obstetric or thrombotic APS, it is conditionally recommended to preventatively treat with a daily aspirin (81-100 mg) starting early in pregnancy and continuing through delivery.

Menopause and Hormone Replacement Therapy

The guidelines make a good practice suggestion to use hormone replacement therapy (HRT) in postmenopausal women with rheumatic disease who do not have lupus or have a positive APL test and who have severe vasomotor symptoms, have no contraindications, and desire treatment.

The guidelines make a conditional recommendation for HRT in women with lupus and without APL. They conditionally recommend against treating with HRT for women with asymptomatic APL and strongly recommend against hormone replacement therapy for women with any form of APS.

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The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

ACR Releases Guideline to Managing Reproductive Health With Comorbid Rheumatic Disease

 about the long-awaited shift that begins March 23, when insulin and certain other biological products transition to a new regulatory pathway, as it amended the definition of “biological product” to match recent statutory changes regarding use of the word “protein.”

In addition, FDA published information for 

 about the changes, stressing that the changes won’t have an impact on access, prescribing practices, or product appearance.

Besides insulin, other biological products include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins.

The changes reduce “regulatory uncertainty,” the FDA said, and “will allow both FDA and private industry to avoid spending time and resources on case-by-case determinations for each product.”

The final rule, “Definition of the Term ‘Biological Product,’” incorporates changes made by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 and language relating to the FDA in the end-of-year spending bill signed into law by the president in December 2019.

The bill, the Further Consolidated Appropriations (FCA) Act, removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the statutory definition of “biological product.” The parenthetical phrase was included in the BPCIA Act definition of  biological product in section 351(i) of the Public Health Service (PHS) Act.

Thus, FDA said Thursday, it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” 

The definition of “protein” would encompass any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.

Starting March 23, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other biological products, will be deemed to be a license for the product under the PHS Act.

Insulin biosimilars approved under the PHS Act will be able to seek interchangeable designations for the first time, and interchangeable insulins will be, pursuant to state laws, eligible for substitution at the pharmacy level.

“This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” FDA Commissioner Stephen M. Hahn, MD, 

So far, only Boehringer lngelheim Pharmaceuticals has announced its intention to seek interchangeability status, for its adalimumab biosimilar, Cyltezo, which cannot launch until at least July 1, 2023, due to a patent settlement with AbbVie, the manufacturer of the originator product, Humira.

Also on March 23, the FDA will remove biologic products approved through New Drug Applications from the Orange Book and into the Purple Book.

The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

FDA Publishes Final Rule for Landmark Shift on Insulins, Other Biological Products

Merck said Wednesday it is spinning off its biosimilars business into a new company, along with women’s health products and other brands, in order to focus on its oncology drug pembrolizumab (Keytruda).

Merck markets a biosimilar infliximab, Renflexis; a biosimilar trastuzumab, Ontruzant; and a biosimilar etanercept, Brenzys, in partnership with Samsung Bioepis.

Another biosimilar from the partnership, 

 referencing Avastin, is under review by the FDA; a decision is expected later this year.

 the new firm “is well-positioned to be a partner in the commercialization of biosimilars worldwide.” It will be headquartered in New Jersey (as is Merck), with about 10,000 to 11,000 employees, and will have approximately 75% of sales generated from markets outside of the United States. The spun off products are expected to generate 2020 revenue of approximately $6.5 billion within Merck; as an independent company from a 2021 base-year of approximately $6.0 billion to $6.5 billion in revenue, the new firm is expected to achieve low-single-digit revenue growth.

The new firm's chief executive officer (CEO) will be Kevin Ali, who has spent about 30 years within Merck.

“Over the past several years, we have purposefully shifted the focus of our efforts and resources to our best opportunities for growth,” said Kenneth C. Frazier, Merck's chairman and CEO.

Sales of the 3 biosimilars were about $250 million last year; sales of pembrolizumab were $11 billion, according to 

Merck to Spin Off Biosimilars Business to Focus on Pembrolizumab 

Reference-based pricing benefit design for prescription drugs led to both increased use of lower-cost therapies within each therapeutic class and a drop in the prices paid by employers and cost sharing borne by employees, according to a new study published Wednesday in 

The technique may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to the authors.

The use of reference-based pricing has been limited in the United States; it is more widely used in Euope. A 

 found that few employers have inplemented the strategy, under which patients are responsible for the cost of a drug or medical service that goes above a specified price.  

The economic evaluation examined 3.3 million drug insurance claims of employees of Catholic organizations who purchased health insurance through the Reta Trust, using a random sample of employees of public sector organizations who purchased insurance through the California Public Employees’ Retirement System (CalPERS) as a comparison group.

The Reta Trust implemented reference pricing in July 2013; CalPERS did not adopt reference pricing during the study period, which ran from July 1, 2010, to December 31, 2017. Data analysis was performed from January 1, 2019, to September 1, 2019.

During the study period, 1.2 million prescriptions were submitted by 34,319 individuals covered by Reta Trust; in the CalPERS group, 2.1 million prescriptions were submitted by 738,159 individuals.

In the first 2.5 years after implementation of reference pricing, the percentage of prescriptions made for the low-priced drug within each therapeutic class increased by 5.1 percentage points (95% CI, 1.8-8.4 percentage points), and patient cost sharing increased by 10.3% (95% CI, −1.6% to −23.6%). The difference was not statistically significant. Meanwhile, the prices paid decreased by 19.1% (95% CI, −30.2% to −6.2%) for Reta Trust patients compared with CalPERS patients.

During the subsequent 2-year postimplementation period, the percentage of prescriptions given for the low-priced drug increased an additional 6.2 percentage points (95% CI, 2.3-10.1 percentage points) and patient cost sharing decreased by 21.3% (95% CI, −31.2% to −9.9%). In addition, prices paid increased by 7.2% (95% CI, −12.6% to 31.4%) and were also not statistically significant.

Relative to the change experienced by the CalPERS patients, the share of prescriptions for lower-priced drugs increased by 6.3 percentage points (8.9% relative increase), the mean prescription drug price decreased by $9.5 (12.1% relative decrease), and the mean patient cost sharing decreased by $1.8 (4.3% relative decrease).

Robinson JC, Whaley C, Brown TT, Dhruva SS. Physician and patient adjustment to reference pricing for drugs [published online February 5, 2020]. 

. doi: 10.1001/jamanetworkopen.2019.20544.

Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday. 

Reference-Based Drug Pricing Shifts Mix of Therapies, Lowers Prices Paid, Study Finds

The FDA and the Federal Trade Commission (FTC) said Monday they agreed to “enhanced collaboration” to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products without making false or misleading statements.

, which will bring together stakeholders from industry, academia, and government agencies; such statements, the departments said, might be discouraging biosimilar uptake.

 it will review patent settlement agreements involving biosimilars to prevent antitrust violations.

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products

, addresses questions developers may have when creating FDA-regulated promotional materials for reference products and biosimilars. FDA guidance documents do not set legally enforceable regulations but describe the agency’s current thinking on a topic. Comments on the draft guidance are being accepted today to April 6, and the FDA said that the measures announced this week are a deliverable of the Biologics Price Competition and Innovation Act, which created the pathway for biosimilar approval in the United States.

The guidance addresses how firms should identify reference and biosimilar products in promotional materials. According to the FDA, both types of biological products, originator products and biosimilars, may be identified by their proprietary name, nonproprietary or proper name, or core name, depending on the context. A proprietary name means the trademark or brand name, a proper name is the nonproprietary name designated by the FDA, and a core name is the component shared among the reference product and any related biological product, biosimilar product, or interchangeable product.

The guidance also addresses what kind what data from studies should be used in the advertising materials that are relevant for both. As an example, the FDA cited a situation where a biosimilar is licensed for fewer conditions than a reference product; in this case, the biosimilar's FDA-approved labeling would contain the information from the reference product’s approved labeling that is relevant to the approved conditions for the biosimilar.

What is likely to be deemed false or misleading question? According to the FDA, “Representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar, such as promotional presentations representing or suggesting that a reference product is safer or more effective than its biosimilar product, or that a biosimilar is safer or more effective than its reference product, are likely to be false or misleading.” This also goes for impressions that a biosimilar is not highly similar to the originator, the document says.

FTC’s involvement in the biosimilars market

 came up several times in 2019 in various congressional hearings about drug pricing as well as proposed legislation.

A role for the FTC was included in the Affordable Prescriptions for Patients Act of 2019 (S. 1416) but the bipartisan bill was blocked late last year by Senate Majority Leader Chuck Schumer, D-New York.

 introduced in the House of Representative, HR 2387, Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019, codified the FDA’s plan to the decide if citizen petitions are abusive and meant to stall a generic drug’s approval, and it directs the HHS secretary to report such petitions to the FTC.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

FDA, FTC Pledge Close Cooperation to Create Biosimilar Competition

The FDA released another set of changes this week, this time changing how abbreviated new drug applications (ANDAs) are prioritized for review so that the agency’s resources are allocated to generic drugs that would have the biggest impact on public health.

Before, “roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities,” 

 Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements

, the FDA prioritized submissions from first filers and from applicants with paragraph IV certifications, even though the drugs would not be able to come to market for years due to a patent, 30-month stay, or exclusivity blocking final approval. A paragraph IV certification is a generic applicant’s assertion that the brand-name product’s patents listed in the Orange Book are invalid, unenforceable, or will not be infringed by the proposed generic product.

, the FDA said; wider access could have the effect of “potentially lowering costs by expediting the availability of safe, high-quality, effective generic medicines in areas of the market with limited competition,” said Choe.

Under the change, an original ANDA must meet certain criteria in order to have a priority review. Those include:

An explicit request from the applicant at the time of submission that includes the prioritization factor or factors under which the applicant believes the submission qualifies for priority review

The FDA determines that the submission relates to a drug shortage or public health emergency.

Among other things, prioritization factors include:

Submissions for which there are not more than 3 approved drug products

Applications containing a paragraph IV certification

Submissions for which final approval is dependent on the expiration of a patent or NDA exclusivity

Submissions for “sole source” drug products

The change applies to both regular generic drugs as well as complex generics, which generally mean drugs with complex active ingredients, complex formulations, complex routes of delivery, or complex dosage forms.

Separately, the House Energy and Commerce Committee made a bipartisan request earlier this month to FDA Commissioner Stephen Hahn, MD, asking for additional information about the approval process for complex generic drugs. 

, the representatives want information about whether the agency’s “initiatives and commitments are sufficient to address the particular challenge of approving complex generic drugs” and to find out if “additional authority is needed to improve the approval process for complex generic drugs to increase access and reduce costs.”

Among other things, the committee asked for a list of list of all complex generic drugs approved by FDA since October 1, 2016, including the date of the first submission, the dates of other milestones and the date of approval, and the number of pre-ANDA meeting requests that FDA has received each year since the program was launched, the number of pre-ANDA meetings that FDA has held each year, and. the number of ANDAs that have been submitted for products discussed during these meetings.

In an effort to speed more generic drug approvals, the FDA said it is changing how it assigns priority review status to abbreviated new drug applications.

FDA Revamps Policy for Prioritizing Generic Drug Applications in Effort to Widen Access

Samsung Bioepis and AffaMed Therapeutics said Friday that the China National Medical Products Administration (NMPA) cleared a phase 3 trial to begin for SB12, a biosimilar eculizumab referencing Soliris.

Also referred to as AMT904 in China, the eculizumab biosimilar treats paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening disease of the blood characterized by destruction of red blood cells, presence of blood clots, and impaired bone marrow function.

It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

, which has responsibility for its global clinical trials in 10 countries.

AffaMed is responsible for the approval of SB12/AMT904 in China, based on the ongoing global phase 3 trial conducted by Samsung Bioepis; it also has received exclusive rights to commercialize the treatment in China and Singapore.

“We are very pleased to announce the CTA approval of SB12 in China as it allows us to expand our global Phase 3 clinical trial to include Asian market,” said Il Sun Hong, vice president, clinical operations, Samsung Bioepis, in a statement. “The clinical collaboration with AffaMed furthers Samsung Bioepis’ goal to innovate access to life-changing medicines for patients in need.”

“We are delighted for this CTA approval as it further validates AffaMed’s position as a clinical-stage biopharmaceutical company” said Nathan Pang, MBBS, chief executive officer, AffaMed Therapeutics. “This is AffaMed’s second biosimilar candidate to receive CTA approval within one-year of founding, accelerating its goal of providing innovative medicines to Chinese patients improving accessibility.”

The approved clinical trial is part of Samsung Bioepis’ ongoing global phase 3 trial, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and reference eculizumab.. The trial, which started in August 2019, is expected to enroll 50 subjects globally. The first Chinese patient visit is scheduled in the first quarter of 2020.

In addition to eculizumab, the 2 companies are collaborating across a number of biosimilar candidates in China, including biosimilar ranibizumab and aflibercept.

In the United States, the reference eculizumab is approved by the FDA to treat atypical hemolytic uremic syndrome (a rare disease that causes abnormal blood clots to form in the small blood vessels in the kidneys), generalized myasthenia gravis (a rare, autoimmune, neuromuscular junction disorder), and, PNH, and, most recently, neuromyelitis optica spectrum disorder (NMOSD, a rare disorder of the central nervous system).

Soliris, a C5 complement inhibitor, is made by rare disease drug maker 

. Another possible competitor to Soliris is Amgen’s ABP 959.

China Clears Phase 3 Trial for SB12, Samsung Bioepis' Biosimilar Eculizumab

Sorrento Therapeutics said this week that its partner Mabpharm has filed a New Drug Application for its proposed infliximab biosimilar in China, and that it also 

plans a 2020 Biologics License Application

 (BLA) in the United States for a “biobetter” of infliximab.

 are an emerging class of follow-on biologics that could compete with biosimilars for market share. While the term “biosimilar” is applied to a drug that has been demonstrated to be highly similar to its reference, with no clinically meaningful differences from the originator product, the term “biobetter” refers to a therapy that has resulted from intentionally altering a biologic product in order to improve its clinical effects, require less frequent administration, or enhance tolerability.

Originator infliximab is sold as Remicade by Janssen.

Sorrento, through a global licensing agreement with Mabpharm, owns the global rights to Mabpharm’s infliximab biobetter antibody outside of China. Sorrento said it is planning to file all the required document for a BLA by the end of 2020.

In response to a query from The Center for Biosimilars

, a Sorrento company spokeswoman said the biobetter’s route of administration will be by infusion, but “the biobetter is expected to have some clinical differentiation (safety/efficacy).”

Mabpharm recently submitted a New Drug Application with China’s National Medical Products Administration for a biobetter anti—tumor necrosis factor-alpha chimeric monoclonal antibody based on infliximab, using a system of Chinese hamster ovary cells; the company said that results in a “potentially better safety profile and lower immunogenicity.”

Thus far, the only biobetter option to be approved in any regulatory territory is Celltrion Healthcare’s Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis; it was approved by the European Commission last year.

Sorrento Therapeutics said this week it plans a 2020 Biologics License Application in the United States for a “biobetter” of infliximab.

Mabpharm Files for Infliximab Biosimilar in China; Sorrento to Seek US Biobetter Version

Novo Nordisk this month launched its authorized generics of NovoLog and NovoLog mix, available at a 50% list price discount compared with its brand-name versions. The announcement came as part of a package that Novo Nordisk said was aimed at making 

The move comes 3 months before the March 2020 transition of insulin to regulation as biologics and biosimilars rather than drugs and generics; 

 announced the authorized generics last fall.

Also beginning this month: a previously-announced plan to allow patients to purchase up to 3 vials or 2 packs of pens for any combination of insulin for a flat fee of $99; the company has said it expects that amount of medication is sufficient for 1 month.

Lastly, the company also said it would offer a 1-time insulin supply option for no cost for when supply has run out and the patient might be in danger of skipping or rationing their doses. The supply would include 3 vials or 2 packs of pens for those with a prescription. 

Last year, stories of insulin rationing by patients were heard at various hearings before Congressional committees discussing the issue of high drug costs in America. A report last June said 

The FDA is hoping that the transition to regulating insulin as a biologic in March will help 

The transition will take time, a company executive told The Center for Biosimilars

 Monday, as it announced an expansion of its 

“I don’t see that this is going to be like a switch that goes off and there is an immediate transition,” said Todd Hobbs, MD, vice president and chief medical officer of Novo Nordisk in North America. Rather, he said, the change will probably encourage other developers to join the field and “lead to more competition down the line.”

Hobbs also said that for the first time, Novo Nordisk would have what he described as a “presence” at the 38

 Annual J.P. Morgan Healthcare Conference, with presentations likely geared towards their future pipeline.

On Monday, the FDA expanded the company's fast-acting mealtime insulin aspart, marketed as Fiasp, for use in children as young as two. The product was first approved by the FDA in 2017 for adults for use by intravenous injection in a medical setting or by subcutaneous multiple daily injections. Last fall the product was also approved for use in insulin infusion pumps.

The dosing options for children are the same as adults, and Hobbs said it is priced at the same as NovoLog. 

Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.

Novo Nordisk Launches Authorized Generic Insulins, Gets FDA Approval for Fast-Acting Insulin in Pediatric Population

Pfizer announced Monday that its bevacizumab biosimilar, Zirabev, has launched and will be available next week.

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said. In an email to The Center for Biosimilars

, a company spokeswoman said "the medication will be available for shipment from Pfizer the week of January 13."

The biosimilar was approved in June 2019 by the FDA for the treatment of metastatic colorectal cancer, recurrent or metastatic nonsquamous non—small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.

It also earned the European Commission’s approval in February 2019 after having received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2018.

Last year, attorneys for both Genentech, which sells Avastin, and Pfizer entered a joint stipulation of dismissal of their patent litigation over bevacizumab. The stipulation stated that the parties are voluntarily dismissing all claims and counterclaims of an April 2019 complaint without prejudice. In the original complaint, Genentech alleged that Pfizer had not produced all necessary information concerning the biosimilar to Genentech, and also claimed that the biosimilar would infringe 23 of its patents.

News about the next bevacizumab biosimilar is not expected until later in the year. Last November, the FDA accepted for review SB8, a proposed bevacizumab biosimilar from Samsung Bioepis.

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said.