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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast® updates below.

Pearce IP BioBlast®: w/e 23 July 2021

July 26, 2021

19 Jul 21 | Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.

19 Jul 21 | Samsung Bioepis announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

20 Jul 21 | Sorrento announced that China’s NMPA has granted marketing approval for Mabpharm’s infliximab ‘biobetter’. Sorrento holds exclusive commercial rights to the product outside of China and disclosed that it plans to file a BLA in the EU and US in 2021.

22 Jul 21 | Inhalon Biopharma announced it will partner with Celltrion to develop IN-006, an inhaled form of regdanvimab for the treatment of COVID-19. It is hoped that the product will be able to reach the virus in the airways and allow patients to self-administer treatment at home. Last week we reported that regdanvimab demonstrated strong neutralising activity against the Delta variant of COVID-19 in pre-clinical studies.

22 Jul 21 | Intas Pharma announced it has signed a commercialisation agreement with Meiji and Dong-A St for DMB-3115 (proposed ustekinumab biosimilar). Under the agreement, Intas will receive exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.

22 Jul 21 | A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

23 Jul 21 | US | Pfizer and Johnson & Johnson (J&J) settled the antitrust litigation relating to Pfizer’s Inflectra® (infliximab biosimilar). Pfizer had alleged that J&J’s payer contracts restricted the use of Inflectra® by denying reimbursement unless Remicade was first proven ineffective for patients, causing a reluctance among pharmacies to stock Inflectra®. Details of the settlement have not been published.

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Pearce IP BioBlast®: w/e 16 July 2021

July 19, 2021

12 Jul 21 | Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

13 Jul 21 | As published in Nature Communications, Australian researchers from the Doherty Institute and Peter MacCallum Cancer Centre were successful in harnessing CRISPR to target the virus that causes COVID-19 and suppress viral replication in mammalian cells.

14 Jul 21 | US | The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro injection compared to a prefilled syringe. Amgen must provide a written response within 15 working days from the date of receipt of the letter.

14 Jul 21 | UK | The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

15 Jul 21 | Bio-Thera Solutions announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).

16 Jul 21 | Celltrion announced pre-clinical in vivo studies of CT-P59 (regdanvimab) demonstrated strong neutralising activity against the Delta variant of COVID-19. Celltrion reported a 100% survival rate after a clinically relevant dose compared to 0% for the placebo group, with significant protection against body weight loss after viral challenge. A therapeutic dosage of CT-P59 also significantly reduced the viral load and inflammation in the lungs compared to non-treated controls.

Pearce IP BioBlast®: w/e 09 July 2021

July 12, 2021

05 Jul 21 | Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, Saudi Arabia, UAE, Kuwait Qatar and Bahrain.

06 Jul 21 | Alvotech announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study for AVT04 (proposed ustekinumab biosimilar). The trial is being conducted in Central and Eastern Europe and approximately 530 patients are expected to be enrolled in the study.

06 Jul 21 | US | Merck announced that the FDA has approved an expanded label for Keytruda® (pembrolizumab). Keytruda® is now also approved for the treatment of patients with recurrent of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

06 Jul 21 | CA | The Government of Quebec released the details of its biosimilars switching program. Under the new program, patients will continue to be reimbursed for biologics for ongoing treatment until 13 April 2022. After this date, patients will only be reimbursed for biologics for which there is no covered biosimilar version, the request is for a pregnant woman or child, or there is a case of a therapeutic failure.

06 Jul 21 | IN | India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.

06 Jul 21 | Opthea announced the FDA has granted fast track designation for OPT-302 (VEGF-C/-D ‘trap’ inhibitor). OPT-302 (a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3)) is intended to treat neovascular (wet) age-related macular degeneration in combination with anti-VEGF-A therapy.

06 Jul 21 | AU | Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

09 Jul 21 | US | US President Biden signed an executive order aimed at promoting competition in the US economy. The order directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, and encourages the FTC to ban ‘pay for delay’ agreements.

Pearce IP BioBlast®: w/e 02 July 2021

July 5, 2021

27 Jun 21 | CN | Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma.

28 Jun 21 | Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while Teva will gain commercialisation rights in Europe, Canada, Israel and New Zealand.

29 Jun 21 | EU | Bioeq announced that it has submitted the MAA for FYB201 (proposed ranibizumab biosimilar) to the EMA. Under the agreement announced on 28 June 2021, FYB201 will be marketed in the EU by Teva.

29 Jun 21 | A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lung cancer.

29 Jun 21 | STADA and XBrane BioPharma announced that Xlucane™ (proposed ranibizumab biosimilar) met its primary endpoint in a pivotal comparability trial. STADA disclosed that it plans to submit the MAA and BLA for Xlucane™ to the EMA and FDA respectively in the second half of 2021.

02 Jul 21 | Gan & Lee Pharmaceuticals announced positive Ph I results for its three proposed insulin analog biosimilars (insulin aspart, insulin lispro and insulin glargine). Gan & Lee announced that all three Ph I studies met their primary PK and primary PD analyses.

Pearce IP BioBlast®: w/e 25 June 2021

June 28, 2021

23 Jun 21 | US |Genentech announced that the FDA has accepted the BLA for its Port Delivery System with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

23 Jun 21 | Innovent Biologics announced its Ph III trials of sintilimab in combination with chemotherapy met the overall survival primary endpoint. 

24 Jun 21 | US | Health insurance provider Cigna announced it will offer a one-time US$500 payment to patients who switch to a biosimilar or another preferred medication. This payment will be provided in a debit card and can be spent on health care services and products.  

24 Jun 21 | EU | The Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indications for Opdivo® (nivolumab) and Rinvoq® (upadacitinib). If approved, Opdivo® will also be indicated for oesophageal or oesophageal junction cancer. If approved, Rinvoq® will also be indicated for atopic dermatitis.  

24 Jun 21 | EU | The CHMP recommended granting conditional marketing authorisation for Minjuvi® (tafasitamab) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, and Abecma® (idecabtagene vicleucel) for the treatment of relapsed and refractory multiple myeloma. 

25 Jun 21 | EU | Samsung Bioepis and Biogen announced that the CHMP has recommended BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization. 

25 Jun 21 | EU | UCB announced that the CHMP has recommended BIMZELX® (bimekizumab) for the treatment of plaque psoriasis. 

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Pearce IP BioBlast®: w/e 18 June 2021

June 21, 2021

10 June 21 | The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.

12 June 21 | Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those reported for the reference product.

15 June 21 | Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

17 June 21 | Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.

17 June 21 | Nichi-Iko announced it has entered a licence and supply agreement with Laboratorio Elea Phoenix for a biosimilar infliximab product. Under the agreement Nichi-Iko will supply the product to Elea for the Argentine market.

Did you know that you can subscribe to Pearce IP’s updates including our weekly BioBlast® and regular pharma and IP industry news? Click here to receive these updates directly in your inbox.